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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K922760
Device Name ATRAUM WOUND DRESSING--MODIFICATION
Applicant
Axiom Medical, Inc.
7625 Rosecrans Ave.
Suite 29/ P.O. Box 1306
Paramount,  CA  90723
Applicant Contact MAHENDRA SANGHVI
Correspondent
Axiom Medical, Inc.
7625 Rosecrans Ave.
Suite 29/ P.O. Box 1306
Paramount,  CA  90723
Correspondent Contact MAHENDRA SANGHVI
Regulation Number880.5090
Classification Product Code
KMF  
Date Received05/28/1992
Decision Date 10/30/1992
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
Predetermined Change
Control Plan Authorized		 No
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