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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrocautery, gynecologic (and accessories)
510(k) Number K905747
Device Name LEEP SYSTEM 6000 ELECTROSURGICAL UNIT AND ACCESSOR
Applicant
COOPERVISION SURGICAL
1963 ROCK ST.
SUITE 17
MOUNTAIN VIEW,  CA  94043
Applicant Contact CHARLES L ROSE
Correspondent
COOPERVISION SURGICAL
1963 ROCK ST.
SUITE 17
MOUNTAIN VIEW,  CA  94043
Correspondent Contact CHARLES L ROSE
Regulation Number884.4120
Classification Product Code
HGI  
Date Received12/24/1990
Decision Date 09/17/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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