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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 K905759
Device Name HASSON STABILIZING ACCESS CANNULA FOR OPEN LAPAROS
Applicant
MARLO SURGICAL TECHNOLOGY
1810 JOSEPH LLOYD PKWY.
WILLOUGHBY,  OH  44094
Applicant Contact SCOTT C MARLOW
Correspondent
MARLO SURGICAL TECHNOLOGY
1810 JOSEPH LLOYD PKWY.
WILLOUGHBY,  OH  44094
Correspondent Contact SCOTT C MARLOW
Regulation Number884.1720
Classification Product Code
HET  
Date Received12/27/1990
Decision Date 03/06/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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