Device Classification Name |
Staple, Implantable
|
510(k) Number |
K060494 |
Device Name |
EASYTAC ANCHOR. EASYTAC DELIVERY SYSTEM |
Applicant |
MEDCHANNEL, LLC |
55 WORCESTER STREET, #3 |
BOSTON,
MA
02118
|
|
Applicant Contact |
FREDERICK TOBIA |
Correspondent |
MEDCHANNEL, LLC |
55 WORCESTER STREET, #3 |
BOSTON,
MA
02118
|
|
Correspondent Contact |
FREDERICK TOBIA |
Regulation Number | 878.4750
|
Classification Product Code |
|
Date Received | 02/24/2006 |
Decision Date | 07/03/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|