The following data is part of a premarket notification filed by Treace Medical, Inc. with the FDA for Ophthalmic Microscope.
Device ID | K822563 |
510k Number | K822563 |
Device Name: | OPHTHALMIC MICROSCOPE |
Classification | Microscope, Operating & Accessories, Ac-powered, Ophthalmic |
Applicant | TREACE MEDICAL, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | HRM |
CFR Regulation Number | 878.4700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-24 |
Decision Date | 1982-09-14 |