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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Ventricular, General & Plastic Surgery
510(k) Number K883887
Device Name AXIOM ATRAUM WOUND DRAINS
Applicant
Axiom, Inc.
7625 Rosecrans Ave.
Suite 29, P.O. Box 1306
Paramount,  CA  90723
Applicant Contact ROGER WOOD
Correspondent
Axiom, Inc.
7625 Rosecrans Ave.
Suite 29, P.O. Box 1306
Paramount,  CA  90723
Correspondent Contact ROGER WOOD
Regulation Number878.4200
Classification Product Code
GBS  
Date Received09/13/1988
Decision Date 02/17/1989
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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