The following data is part of a premarket notification filed by Concept, Inc. with the FDA for Microsurgical Instruments.
Device ID | K823174 |
510k Number | K823174 |
Device Name: | MICROSURGICAL INSTRUMENTS |
Classification | Forceps, Ophthalmic |
Applicant | CONCEPT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HNR |
CFR Regulation Number | 886.4350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-10-26 |
Decision Date | 1982-11-16 |