SYNCRO – BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE


Device Classification Name

tubes, gastrointestinal (and accessories)

510(k) Number K110005
Device Name SYNCRO – BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
Applicant
SYNCRO MEDICAL INNOVATIONS, INC.
342 e main street, suite 207
leola, 
PA 
17540

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

Correspodent Contact william g mclain
Regulation Number 876.5980
Classification Product Code
KNT  
Date Received 01/03/2011
Decision Date 08/04/2011
Decision

substantially equivalent – kit

(SESK)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No