Device Classification Name |
suture, recombinant technology
|
De Novo Number |
DEN060003 |
510(K) Number |
K052225
|
Device Name |
TEPHAFLEX ABSORBABLE SUTURE |
Requester |
tepha, inc. |
840 memorial drive |
cambridge,
MA
02139
|
|
Contact |
mary p legraw |
|
Regulation Number | 878.4494
|
Classification Product Code |
|
Date Received | 05/12/2006 |
Decision Date | 02/08/2007 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General & Plastic Surgery
|
Review Advisory Committee |
General & Plastic Surgery
|
Classification Order |
Classification Order
|
Type |
Post-NSE
|
|
|