The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Micro & Mini-micro Alligator Forceps.
Device ID | K822369 |
510k Number | K822369 |
Device Name: | MICRO & MINI-MICRO ALLIGATOR FORCEPS |
Classification | Forceps, Ent |
Applicant | TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KAE |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-06 |
Decision Date | 1982-09-09 |