Device Classification Name |
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
More FDA Info for this Device |
510(K) Number |
K070715 |
Device Name |
Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
Applicant |
Polyganics BV
L.J. ZIELSTRAWEG 1
GRONINGEN 9713-GX NL
Other 510(k) Applications for this Company
|
Contact |
JAN NIEUWENHUIS
Other 510(k) Applications for this Contact |
Regulation Number |
874.3620
More FDA Info for this Regulation Number |
Classification Product Code |
NHB
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
03/14/2007 |
Decision Date |
05/07/2007 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
EN - Ear, Nose, & Throat |
Review Advisory Committee |
EN - Ear, Nose, & Throat |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|