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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 K910713
Device Name FLYNN TISSUE PROBE AND BLUNT DISSECTOR
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 Received02/20/1991
Decision Date 03/21/1991
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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