FDA 510(k) Application Details - K142022
Device Classification Name |
Microdebrider, Ent, High Speed, Single Use, Reprocessed
More FDA Info for this Device |
510(K) Number |
K142022 |
Device Name |
Microdebrider, Ent, High Speed, Single Use, Reprocessed |
Applicant |
MEDLINE RENEWAL
2747 SW 6th St
REDMOND, OR 97756 US
Other 510(k) Applications for this Company
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Contact |
RICHARD D WYNKOOP
Other 510(k) Applications for this Contact |
Regulation Number |
874.4140
More FDA Info for this Regulation Number |
Classification Product Code |
NLY
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
07/25/2014 |
Decision Date |
12/19/2014 |
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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