The following data is part of a premarket notification filed by Diseases Of The Skin Clinic, P.a. with the FDA for Stereomed Camera.
Device ID | K823534 |
510k Number | K823534 |
Device Name: | STEREOMED CAMERA |
Classification | Camera, Still, Surgical |
Applicant | DISEASES OF THE SKIN CLINIC, P.A. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FTT |
CFR Regulation Number | 878.4160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-11-20 |
Decision Date | 1982-12-15 |