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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K013165
Device Name USA SERIES LAPAROSCOPES
Applicant
Circon Acmi
300 Stillwater Ave.
P.O. Box 1971
Stamford,  CT  06904
Applicant Contact WAYNE B STERNER
Correspondent
Circon Acmi
300 Stillwater Ave.
P.O. Box 1971
Stamford,  CT  06904
Correspondent Contact WAYNE B STERNER
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/21/2001
Decision Date 01/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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