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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 K852241
Device Name AXIOM ATRAUM TROCAR CATHETER
Applicant
Axiom Medical, Inc.
7625 Rosecrans Ave.
Suite 29/ P.O. Box 1306
Paramount,  CA  90723
Applicant Contact JOHN A KEMP
Correspondent
Axiom Medical, Inc.
7625 Rosecrans Ave.
Suite 29/ P.O. Box 1306
Paramount,  CA  90723
Correspondent Contact JOHN A KEMP
Regulation Number878.4200
Classification Product Code
GBS  
Date Received05/23/1985
Decision Date 06/14/1985
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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