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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name forceps, biopsy, gynecological
510(k) Number K852357
Device Name GYNE-SHEAR CERVICAL BIOPSY INSTRUMENT W/DISPIS TIP
Applicant
GYNECO, INC.
51 CHUBB WAY
BRANCHBURG,  NJ  08876
Applicant Contact JANE AOYAGI
Correspondent
GYNECO, INC.
51 CHUBB WAY
BRANCHBURG,  NJ  08876
Correspondent Contact JANE AOYAGI
Regulation Number884.4530
Classification Product Code
HFB  
Date Received06/03/1985
Decision Date 07/05/1985
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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