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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 DRIVE SE
rochester,  MN  55904
Applicant Contact r. d fryar
Correspondent
ROCHESTER MEDICAL CORP.
210 WOODLAKE DRIVE 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
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