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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K914883
Device Name CIRCON ACMI GEN SURG INSTRU FOR MINI INVASIVE SURG
Applicant
Circon Video
300 Stillwater Ave.
P.O. Box Box 1971
Stanford,  CT  06904
Applicant Contact ERVIN F TAYLOR
Correspondent
Circon Video
300 Stillwater Ave.
P.O. Box Box 1971
Stanford,  CT  06904
Correspondent Contact ERVIN F TAYLOR
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/30/1991
Decision Date 01/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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