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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K920611
Device Name MARLOW LAPAROSCOPIC GRASPING FORCEP
Applicant
Marlo Surgical Technology
1810 Joseph Lloyd Pkwy.
Willoughby,  OH  44094
Applicant Contact CRAIG LANESE
Correspondent
Marlo Surgical Technology
1810 Joseph Lloyd Pkwy.
Willoughby,  OH  44094
Correspondent Contact CRAIG LANESE
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received02/11/1992
Decision Date 04/20/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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