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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 K851684
Device Name UROTEC/FRANKLIN SOFT SIMPLASTIC CATHETER
Applicant
Urotec Systems Corp.
1000 California Ave.
Pittsburgh,  PA  15212
Applicant Contact SUNIL WADHWANI
Correspondent
Urotec Systems Corp.
1000 California Ave.
Pittsburgh,  PA  15212
Correspondent Contact SUNIL WADHWANI
Regulation Number876.5130
Classification Product Code
KOD  
Date Received04/23/1985
Decision Date 07/02/1985
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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