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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cannula, Surgical, General & Plastic Surgery
510(k) Number K861306
Device Name SUCTION SYSTEM
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
Regulation Number878.4800
Classification Product Code
GEA  
Date Received04/08/1986
Decision Date 06/09/1986
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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