Device Classification Name |
temporary, internal use hemostatic
|
De Novo Number |
DEN160012 |
Device Name |
D2 Dressing |
Requester |
Z-MEDICA, LLC |
4 fairfield boulevard |
wallingford,
CT
06492
|
|
Contact |
sheila k. wallin |
|
Regulation Number | 878.4454
|
Classification Product Code |
|
Date Received | 03/16/2016 |
Decision Date | 06/30/2017 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General & Plastic Surgery
|
Review Advisory Committee |
General & Plastic Surgery
|
Reclassification Order |
Reclassification Order
|
Type |
Direct
|
|
|