TRACER METRO SMART WIRE GUIDE

Device Classification Name

endoscope and/or accessories

510(k) Number K033754
Device Name TRACER METRO SMART WIRE GUIDE
Applicant
WILSON-COOK MEDICAL, INC.
4900 bethania station rd.
winston-salem, 
NC 
27105

Applicant Contact marge walls-walker
Correspondent
WILSON-COOK MEDICAL, INC.
4900 bethania station rd.
winston-salem, 
NC 
27105

Correspodent Contact marge walls-walker
Regulation Number 876.1500
Classification Product Code
KOG  
Date Received 12/01/2003
Decision Date 12/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No