ENDOFLIP ECD


Device Classification Name

endoscopic access overtube, gastroenterology-urology

510(k) Number K110531
Device Name ENDOFLIP ECD
Applicant
CROSPON, LTD.
24301 woodsage drive
bonita springs, 
FL 
34134

Applicant Contact paul dryden
Correspondent
CROSPON, LTD.
24301 woodsage drive
bonita springs, 
FL 
34134

Correspodent Contact paul dryden
Regulation Number 876.1500
Classification Product Code
FED  
Date Received 02/24/2011
Decision Date 10/06/2011
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