The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Enhance Allograft Wedge Instrument Tray.
| Device ID | K152969 |
| 510k Number | K152969 |
| Device Name: | ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY |
| Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Applicant | CONMED CORPORATION 525 FRENCH ROAD Utica, NY 13502 |
| Contact | Dionne Sanders |
| Correspondent | Dionne Sanders CONMED CORPORATION 525 FRENCH ROAD Utica, NY 13502 |
| Product Code | KCT |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-08 |
| Decision Date | 2016-03-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30845854052062 | K152969 | 000 |