The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Photostar V-8.
Device ID | K871681 |
510k Number | K871681 |
Device Name: | PHOTOSTAR V-8 |
Classification | Colposcope (and Colpomicroscope) |
Applicant | WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford, CT 06460 |
Contact | Vincent Frazzetta |
Correspondent | Vincent Frazzetta WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford, CT 06460 |
Product Code | HEX |
CFR Regulation Number | 884.1630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-04-29 |
Decision Date | 1987-08-05 |