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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stapler, surgical
510(k) Number K850947
Device Name V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS
Applicant
AMERICAN V. MUELLER
6600 W. TOUHY
CHICAGO,  IL  60648
Applicant Contact MATHEW NOWLAND
Correspondent
AMERICAN V. MUELLER
6600 W. TOUHY
CHICAGO,  IL  60648
Correspondent Contact MATHEW NOWLAND
Regulation Number878.4740
Classification Product Code
GAG  
Date Received03/07/1985
Decision Date 04/17/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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