ZUTRON COLONOSCOPE STIFFENING DEVICE


Device Classification Name

endoscope and/or accessories

510(k) Number K051068
Device Name ZUTRON COLONOSCOPE STIFFENING DEVICE
Applicant
ZUTRON MEDICAL
9816 pflumm rd
lenexa, 
KS 
66215

Applicant Contact jordan hartong
Correspondent
ZUTRON MEDICAL
9816 pflumm rd
lenexa, 
KS 
66215

Correspodent Contact jordan hartong
Regulation Number 876.1500
Classification Product Code
KOG  
Date Received 04/26/2005
Decision Date 07/11/2005
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