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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urological
510(k) Number K900509
Device Name NORTA SILICONE ELASTOMER COATED LATEX BALLOON CATH
Applicant
Medical Latex Corp.
Karung Berkunci # 786
80990 Johor Bahru
West Malaysia,  MY
Applicant Contact CHENG CHUAN
Correspondent
Medical Latex Corp.
Karung Berkunci # 786
80990 Johor Bahru
West Malaysia,  MY
Correspondent Contact CHENG CHUAN
Regulation Number876.5130
Classification Product Code
KOD  
Date Received02/02/1990
Decision Date 12/14/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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