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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sling, Arm
510(k) Number K912661
Device Name MATRX, PYRAMID TRIANGLE BANDAGE
Applicant
Matrix Medica, Inc.
145 Mid County Dr.
Orchard Park,  NY 
Applicant Contact JOHN M WYNNE
Correspondent
Matrix Medica, Inc.
145 Mid County Dr.
Orchard Park,  NY 
Correspondent Contact JOHN M WYNNE
Regulation Number890.3640
Classification Product Code
ILI  
Date Received06/18/1991
Decision Date 08/21/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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