PHOTOSTAR V-8

Colposcope (and Colpomicroscope)

WALLACH SURGICAL DEVICES, INC.

The following data is part of a premarket notification filed by Wallach Surgical Devices, Inc. with the FDA for Photostar V-8.

Pre-market Notification Details

Device IDK871681
510k NumberK871681
Device Name:PHOTOSTAR V-8
ClassificationColposcope (and Colpomicroscope)
Applicant WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford,  CT  06460
ContactVincent Frazzetta
CorrespondentVincent Frazzetta
WALLACH SURGICAL DEVICES, INC. 291 PEPE'S FARM RD. Milford,  CT  06460
Product CodeHEX  
CFR Regulation Number884.1630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-29
Decision Date1987-08-05

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