SPEEDICATH


Device Classification Name

catheter, urethral

510(k) Number K023254
Device Name SPEEDICATH
Original Applicant
COLOPLAST CORP.
1940 commerce dr.
north mankato, 
MN 
56003

Original Contact elizabeth boots
Regulation Number 876.5130
Classification Product Code
GBM  
Date Received 09/30/2002
Decision Date 01/27/2003
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

Recalls CDRH Recalls