GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K072787
Device Name GABRIEL BLUE TUBE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE, MODEL GFT-111
Applicant
SYNCRO MEDICAL INNOVATIONS, INC.
342 e main street, suite 207
leola, 
PA 
17540

Applicant Contact william mclain
Correspondent
SYNCRO MEDICAL INNOVATIONS, INC.
342 e main street, suite 207
leola, 
PA 
17540

Correspodent Contact william mclain
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 10/01/2007
Decision Date 10/31/2007
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