VITALCARE URETHRAL CATHETER RED RUBBER


Device Classification Name

catheter, straight

510(k) Number K023872
FOIA Releasable 510(k) K023872
Device Name VITALCARE URETHRAL CATHETER RED RUBBER
Original Applicant
VITALCARE, INC.
15800 nw 13th ave.
miami, 
FL 
33169

Original Contact michael mcavenia
Regulation Number 876.5130
Classification Product Code
EZD  
Subsequent Product Code
GBM  
Date Received 11/20/2002
Decision Date 04/10/2003
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