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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 K973076
Device Name EUROMEDICAL HAEMATURIA FOLEY CATHETER
Applicant
Unomedical Sdn Bhd
Post Office Box 1108
Elfers,  FL  34680
Applicant Contact PATRICK J LAMB
Correspondent
Unomedical Sdn Bhd
Post Office Box 1108
Elfers,  FL  34680
Correspondent Contact PATRICK J LAMB
Regulation Number876.5130
Classification Product Code
EZL  
Date Received08/18/1997
Decision Date 09/16/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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