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
|
|
Correspondent Contact |
WILLIAM G MCLAIN |
Regulation Number | 876.5980
|
Classification Product Code |
|
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
|
|
|