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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, retention type, balloon
510(k) Number K934895
Device Name GLASSMAN SILICONE CATHETER
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 Number876.5130
Classification Product Code
EZL  
Date Received10/05/1993
Decision Date 10/13/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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