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| POSITION | DESCRIPTION |
| 1-9 | 510(K) NUMBER |
| 10-59 | APPLICANT |
| 60-79 | CONTACT |
| 80-109 | STREET 1 |
| 110-139 | STREET 2 |
| 140-164 | CITY |
| 165-166 | STATE OR COUNRTY CODE |
| 167-176 | DOMESTIC ZIP OR FOREIGN POSTAL CODE |
| 177-225 | DEVICE NAME |
| 226-231 | DATE RECEIVED |
| 232-237 | DECISION DATE |
| 238-239 | DECISION |
| 240-241 | ADVISORY COMMITTEE |
| 242-244 | PRODUCT CODE |
| 245-254 | Contains either "SUMMARY" or "STATEMENT"
SUMMARY indicates that a summary of safety and effectiveness information is available from FDA |
| 255-256 | Contains the Advisory Committee Code under which the product was classified, based on the product code |
| 257 | Contains one of the following indicators:
m = Summary only |
| 258-268 | Denotes the type of 510(k) submission:
Traditional |
| 269 | Blank |
| 270 | Third Party Flag - Y or N - Indicates if the 510(k) was reviewed by a Third Party |
| 271 | Expedited Review Flag - Y, N or null - Indicates if the 510(k) was granted expedited review status. |
| 272 | "X" End of Record marker |
| KD | Substantially Equivalent - Kit with Drugs |
| PR | Substantially Equivalent - Proposed Recision |
| PT | Substantially Equivalent - Subject to Tracking & PMS |
| RN | Substantially Equivalent - Rescind Non-Substantial Equivalence |
| SA | Substantially Equivalent - Awaiting Device Approval |
| SD | Substantially Equivalent with Drug |
| SE | Substantially Equivalent |
| SF | Substantially Equivalent - Awaiting Future Policies |
| SI | Substantially Equivalent - Market after Inspection |
| SK | Substantially Equivalent - Kit |
| SN | Substantially Equivalent for Some Indications |
| SP | Substantially Equivalent - PostMarket Surveillance Required |
| ST | Substantially Equivalent - Subject to Tracking Reg. |
| SW | Substantially Equivalent - Awaiting Drug Approval |
| FB | Subject to 515(b) - Requires PMA |
| NE | Not Substantially Equivalent |
| SC | Not Substantially Equivalent - Cannot Market |
| SL | Not Substantially Equivalent - Improper Label |
| RE | Rescind Substantial Equivalence |
| UD | Unable to Determine Equivalence |
| UO | Unable to Determine Equivalence - Outstanding Drug Issue |
| UR | Not Substantially Equivalent - Unreliable Data |
| OD | Unable to Determine Equivalence - Outstanding Device Issue |
| CR | Additional Information Requested; Applicant can not respond within 30 days |
| DB | Forwarded to Drugs/Biologics |
| DD | Deleted/Duplicate |
| DE | Deleted |
| DR | Drug (CDER) Review Required |
| EX | Exempted by Regulation |
| GP | General Purpose Article |
| K4 | Closeout Letter Issued |
| NA | Not Actively Regulated |
| ND | Not a Device |
| NF | Not a Finished Product |
| NR | Not a Required Submission |
| PE | Preamendment Exempt |
| RC | Reconditioner/Remanufacturer |
| TR | Transitional Device |
| WD | Withdrawn by Applicant |
(Updated 5/6/02)
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