MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K021991
Device Name MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE
Original Applicant
SYNCRO MEDICAL INNOVATIONS, INC.
433 cherry street, ll#6
macon, 
GA 
31201 -7950

Original Contact sabry a gabriel
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 06/18/2002
Decision Date 07/18/2002
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