The following data is part of a premarket notification filed by Microtek Medical, Inc. with the FDA for Mcgee Forceps.
Device ID | K833607 |
510k Number | K833607 |
Device Name: | MCGEE FORCEPS |
Classification | Forceps, Ent |
Applicant | MICROTEK MEDICAL, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KAE |
CFR Regulation Number | 874.4420 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-12 |
Decision Date | 1984-01-03 |