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 |