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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Urethral
510(k) Number K031409
Device Name URINARY CATHETERS
Applicant
PROMEDIC, INC.
6329 WEST WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
Applicant Contact PAUL DRYDEN
Correspondent
PROMEDIC, INC.
6329 WEST WATERVIEW CT.
MCCORDSVILLE,  IN  46055 -9501
Correspondent Contact PAUL DRYDEN
Regulation Number876.5130
Classification Product Code
GBM  
Date Received05/05/2003
Decision Date 06/17/2003
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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