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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
510(k) Number K884306
Device Name BICAP ABLATING FORCEPS BAF-7
Applicant
CIRCON ACMI
300 STILLWATER AVE.
P.O. BOX 1971
STAMFORD,  CT  06904 -1971
Applicant Contact TAYLOR, PE
Correspondent
CIRCON ACMI
300 STILLWATER AVE.
P.O. BOX 1971
STAMFORD,  CT  06904 -1971
Correspondent Contact TAYLOR, PE
Regulation Number876.4300
Classification Product Code
KNS  
Date Received10/13/1988
Decision Date 01/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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