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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K852614
Device Name ATRAUM WOUND DRESSING
Applicant
Axiom Medical, Inc.
7625 Rosecrans Ave.
Suite 29/ P.O. Box 1306
Paramount,  CA  90723
Applicant Contact ROGER WOOD
Correspondent
Axiom Medical, Inc.
7625 Rosecrans Ave.
Suite 29/ P.O. Box 1306
Paramount,  CA  90723
Correspondent Contact ROGER WOOD
Classification Product Code
FRO  
Date Received06/20/1985
Decision Date 08/30/1985
Decision Substantially Equivalent (SESE)
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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