FDA 510(k) Application Details - K152958
Device Classification Name |
Polymer, Ear, Nose And Throat, Synthetic, Absorbable
More FDA Info for this Device |
510(K) Number |
K152958 |
Device Name |
Polymer, Ear, Nose And Throat, Synthetic, Absorbable |
Applicant |
SPIROX, INC.
3475-O EDISON WAY
MENLO PARK, CA 94025 US
Other 510(k) Applications for this Company
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Contact |
MIKE ROSENTHAL
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 |
10/07/2015 |
Decision Date |
12/04/2015 |
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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