FDA 510(k) Application Details - K092590
| Device Classification Name |
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
More FDA Info for this Device |
| 510(K) Number |
K092590 |
| Device Name |
Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
| Applicant |
ETHICON, INC.
U.S. ROUTE 22, WEST
P.O. BOX 151
SOMERVILLE, NJ 08876-0151 US
Other 510(k) Applications for this Company
|
| Contact |
LESLIE YOUNG
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 |
08/24/2009 |
| Decision Date |
02/17/2010 |
| 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 |
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FDA Source Information for K092590
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