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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K905706
Device Name GYN-1500 HYSTEROSCOPIC INUFFLATOR
Applicant
CIRCON ACMI
300 STILLWATER AVE.
P.O. BOX 1971
STAMFORD,  CT  06904 -1971
Applicant Contact ERVIN F TAYLOR
Correspondent
CIRCON ACMI
300 STILLWATER AVE.
P.O. BOX 1971
STAMFORD,  CT  06904 -1971
Correspondent Contact ERVIN F TAYLOR
Regulation Number884.1700
Classification Product Code
HIG  
Date Received12/24/1990
Decision Date 02/28/1991
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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