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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 K944563
Device Name FAMILY OF PRIMUS FORCEPS: GRASPERS/DISSECTORS/SUTURERS/NEEDLE DRIVERS
Applicant
Marlow Surgical Technologies, Inc.
1810 Joseph Lloyd Pkwy.
Willoughby,  OH  44094
Applicant Contact ARTHUR S GODDARD
Correspondent
Marlow Surgical Technologies, Inc.
1810 Joseph Lloyd Pkwy.
Willoughby,  OH  44094
Correspondent Contact ARTHUR S GODDARD
Regulation Number884.1720
Classification Product Code
HET  
Date Received09/19/1994
Decision Date 12/27/1994
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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