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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 K863247
Device Name AXIOM TROCAR THORACIC CATHETER
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 Number878.4200
Classification Product Code
GBS  
Date Received08/22/1986
Decision Date 08/29/1986
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
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