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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Laparoscopic
510(k) Number K914101
Device Name CIRCON ACMI CAT.# LAP 9900; HIGH FLOW INSUFFLATOR
Applicant
CIRCON VIDEO
300 STILLWATER AVE.
P.O. BOX BOX 1971
STANFORD,  CT  06904 -1971
Applicant Contact ERVIN F TAYLOR
Correspondent
CIRCON VIDEO
300 STILLWATER AVE.
P.O. BOX BOX 1971
STANFORD,  CT  06904 -1971
Correspondent Contact ERVIN F TAYLOR
Regulation Number884.1730
Classification Product Code
HIF  
Date Received09/12/1991
Decision Date 11/22/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
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