The following data is part of a premarket notification filed by Conmed Corporation with the FDA for Detachatip Iii Plus Instrument Tray Model 3-4343.
Device ID | K123175 |
510k Number | K123175 |
Device Name: | DETACHATIP III PLUS INSTRUMENT TRAY MODEL 3-4343 |
Classification | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
Applicant | CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
Contact | Anna D'lima |
Correspondent | Anna D'lima CONMED CORPORATION 525 FRENCH RD. Utica, NY 13502 |
Product Code | KCT |
CFR Regulation Number | 880.6850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-10-09 |
Decision Date | 2013-02-21 |
Summary: | summary |