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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Surgical, Disposable
510(k) Number K903649
Device Name BRADLEY TENACULUM HOLDER
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 Number878.4800
Classification Product Code
KDC  
Date Received08/13/1990
Decision Date 11/02/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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