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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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