Device Classification Name |
Polymer, Ent Synthetic, Porous Polyethylene
More FDA Info for this Device |
510(K) Number |
K083621 |
Device Name |
Polymer, Ent Synthetic, Porous Polyethylene |
Applicant |
POREX SURGICAL, INC.
15 DART RD.
NEWNAN, GA 30265 US
Other 510(k) Applications for this Company
|
Contact |
JERRI L MANN
Other 510(k) Applications for this Contact |
Regulation Number |
874.3620
More FDA Info for this Regulation Number |
Classification Product Code |
JOF
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
12/08/2008 |
Decision Date |
02/03/2009 |
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 |
|