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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Suction, Endometrial (And Accessories)
510(k) Number K853216
Device Name MASTER ENDOMET BIOPSY KIT W/PLAS CURE 3,4MM-4003,4
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 Number884.1175
Classification Product Code
HHK  
Date Received08/01/1985
Decision Date 04/02/1986
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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