ENDO-GLIDE GUIDEWIRE


Device Classification Name

endoscope and/or accessories

510(k) Number K023603
Device Name ENDO-GLIDE GUIDEWIRE
Original Applicant
ENDO-THERAPEUTICS, INC.
1183 cedar st.
safety harbor, 
FL 
34695 -2908

Original Contact todd adkisson
Regulation Number 876.1500
Classification Product Code
KOG  
Subsequent Product Code
GCA  
Date Received 10/28/2002
Decision Date 02/19/2003
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