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FDA 510(k) Application Details - K013696
Device Classification Name
Button, Nasal Septal
More FDA Info for this Device
510(K) Number
K013696
Device Name
Button, Nasal Septal
Applicant
SILMED, INC.
3987 LAKEVIEW TRAIL
LEESBURG,, IN 46538 US
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Contact
RAMA GUNDLAPALLI
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
LFB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/07/2001
Decision Date
11/28/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
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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