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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 K853389
Device Name WALLACH ZOOM COLPOSCOPE
Applicant
WALLACH SURGICAL DEVICES, INC.
273 LINWOOD AVE.
FAIRFIELD,  CT  06430
Applicant Contact RONALD RZASA
Correspondent
WALLACH SURGICAL DEVICES, INC.
273 LINWOOD AVE.
FAIRFIELD,  CT  06430
Correspondent Contact RONALD RZASA
Regulation Number884.1630
Classification Product Code
HEX  
Date Received08/13/1985
Decision Date 11/19/1985
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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