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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, irrigation
510(k) Number K965146
Device Name FLAT CLOSED WOUND DRAIN WITH TROCAR
Applicant
AXIOM MEDICAL, INC.
555 WEST VICTORIA ST.
RANCHO DOMINGUEZ,  CA  90220
Applicant Contact RIDWAN HARDY
Correspondent
AXIOM MEDICAL, INC.
555 WEST VICTORIA ST.
RANCHO DOMINGUEZ,  CA  90220
Correspondent Contact RIDWAN HARDY
Regulation Number878.4200
Classification Product Code
GBX  
Date Received12/23/1996
Decision Date 03/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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