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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Suprapubic (And Accessories)
510(k) Number K852200
Device Name SIMPLASTIC SUPRA PUBIC CATHETER
Applicant
Franklin Medical USA, Inc.
340 Interstate N.
Suite 140
Atlanta,  GA  30339
Applicant Contact HUNG
Correspondent
Franklin Medical USA, Inc.
340 Interstate N.
Suite 140
Atlanta,  GA  30339
Correspondent Contact HUNG
Regulation Number876.5090
Classification Product Code
KOB  
Date Received05/21/1985
Decision Date 08/07/1985
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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