GUIDEWIRE, MODEL G-V220-3527S AND OTHERS


Device Classification Name

endoscopic guidewire, gastroenterology-urology

510(k) Number K072354
Device Name GUIDEWIRE, MODEL G-V220-3527S AND OTHERS
Applicant
ACCELLENT INC.
100 fordham road
wilmington, 
MA 
01887

Applicant Contact karl steineck
Correspondent
ACCELLENT INC.
100 fordham road
wilmington, 
MA 
01887

Correspodent Contact karl steineck
Regulation Number 876.1500
Classification Product Code
OCY  
Date Received 08/22/2007
Decision Date 12/07/2007
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