Device Classification Name |
wound dressing with animal-derived material(s)
|
510(k) Number |
K092096 |
Device Name |
ENDOFORM DERMAL TEMPLATE |
Applicant |
MESYNTHES LTD |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760 -4153
|
|
Applicant Contact |
MARY MCNAMARA |
Correspondent |
MESYNTHES LTD |
49 PLAIN STREET |
NORTH ATTLEBORO,
MA
02760 -4153
|
|
Correspondent Contact |
MARY MCNAMARA |
Classification Product Code |
|
Date Received | 07/14/2009 |
Decision Date | 01/21/2010 |
Decision |
Substantially Equivalent
(SESE) |
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|