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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Culdoscope (And Accessories)
510(k) Number K954311
Device Name KOH COLPOTOMIZER SYSTEM
Applicant
COOPERSURGICAL, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Applicant Contact MARY M MCNAMARA
Correspondent
COOPERSURGICAL, INC.
49 PLAIN ST.
NORTH ATTLEBORO,  MA  02760
Correspondent Contact MARY M MCNAMARA
Regulation Number884.1640
Classification Product Code
HEW  
Date Received09/15/1995
Decision Date 11/19/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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