ENDOFLIP GASTRIC TUBE


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K110529
Device Name ENDOFLIP GASTRIC TUBE
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 876.5980
Classification Product Code
KNT  
Date Received 02/24/2011
Decision Date 07/22/2011
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