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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 K945806
Device Name SILICATH ALL SILICONE FOLEY CATHETER
Applicant
UNOMEDICAL SDN BHD
BAKAR ARANG INDUSTRIAL ESTATE
P.O. BOX 18
SUNGAI PETANI, KEDAH,  MY 08007
Applicant Contact LIM K KANG
Correspondent
UNOMEDICAL SDN BHD
BAKAR ARANG INDUSTRIAL ESTATE
P.O. BOX 18
SUNGAI PETANI, KEDAH,  MY 08007
Correspondent Contact LIM K KANG
Regulation Number876.5130
Classification Product Code
EZL  
Date Received11/28/1994
Decision Date 03/21/1995
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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