FROG


Device Classification Name

tube, feeding

510(k) Number K072831
Device Name FROG
Applicant
NEWBY-COOMBS, LLC
21 union turnpike
branchville, 
NJ 
07826

Applicant Contact karla coombs
Correspondent
NEWBY-COOMBS, LLC
21 union turnpike
branchville, 
NJ 
07826

Correspodent Contact karla coombs
Regulation Number 876.5980
Classification Product Code
FPD  
Date Received 10/03/2007
Decision Date 12/12/2008
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