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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Straight
510(k) Number K040519
Device Name SLIP UROLOGY CATHETER
Applicant
PERCUTANEOUS SYSTEMS, INC.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Applicant Contact HOWARD M HOLSTEIN
Correspondent
PERCUTANEOUS SYSTEMS, INC.
555 THIRTEENTH STREET, NW
WASHINGTON,  DC  20004
Correspondent Contact HOWARD M HOLSTEIN
Regulation Number876.5130
Classification Product Code
EZD  
Date Received02/27/2004
Decision Date 05/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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