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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name colposcope (and colpomicroscope)
510(k) Number K871681
Device Name PHOTOSTAR V-8
Applicant
WALLACH SURGICAL DEVICES, INC.
291 PEPE'S FARM RD.
MILFORD,  CT  06460
Applicant Contact VINCENT FRAZZETTA
Correspondent
WALLACH SURGICAL DEVICES, INC.
291 PEPE'S FARM RD.
MILFORD,  CT  06460
Correspondent Contact VINCENT FRAZZETTA
Regulation Number884.1630
Classification Product Code
HEX  
Date Received04/29/1987
Decision Date 08/05/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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