PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL


Device Classification Name

colonoscope and accessories, flexible/rigid

510(k) Number K081004
Device Name PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL
Applicant
STRYKER GI
1420 lakeside parkway, #110
flower mound, 
TX 
75028

Applicant Contact tiffani rogers
Correspondent
STRYKER GI
1420 lakeside parkway, #110
flower mound, 
TX 
75028

Correspodent Contact tiffani rogers
Regulation Number 876.1500
Classification Product Code
FDF  
Date Received 04/08/2008
Decision Date 05/02/2008
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