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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laparoscope, gynecologic (and accessories)
510(k) Number K942973
Device Name HASSON STABILIZING ACCESS CANNULA (SAC)
Applicant
ENTEC CORP.
8 BISHOP LN.
MADISON,  CT  06443
Applicant Contact HERB D'ALO
Correspondent
ENTEC CORP.
8 BISHOP LN.
MADISON,  CT  06443
Correspondent Contact HERB D'ALO
Regulation Number884.1720
Classification Product Code
HET  
Date Received06/20/1994
Decision Date 02/27/1995
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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