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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 K913954
Device Name MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS
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 Number876.1500
Classification Product Code
GCJ  
Date Received09/05/1991
Decision Date 12/18/1991
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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