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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 K896053
Device Name ALL SILICONE FOLEY CATHETER
Applicant
Rochester Medical Corp.
210 Woodlake Dr. SE
Rochester,  MN  55904
Applicant Contact R. D FRYAR
Correspondent
Rochester Medical Corp.
210 Woodlake Dr. SE
Rochester,  MN  55904
Correspondent Contact R. D FRYAR
Regulation Number876.5130
Classification Product Code
KOD  
Date Received10/18/1989
Decision Date 02/12/1990
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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