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FDA 510(k) Application Details - K082276
Device Classification Name
Splint, Intranasal Septal
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510(K) Number
K082276
Device Name
Splint, Intranasal Septal
Applicant
SYNTHEMED, INC.
200 MIDDLESEX ESSEX TPK.
SUITE 210
ISELIN, NJ 08830 US
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ELI PINES
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Regulation Number
874.4780
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Classification Product Code
LYA
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Date Received
08/11/2008
Decision Date
11/18/2008
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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