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FDA 510(k) Application Details - K141423
Device Classification Name
Splint, Intranasal Septal
More FDA Info for this Device
510(K) Number
K141423
Device Name
Splint, Intranasal Septal
Applicant
Polyganics BV
ROZENBURGLAAN 15A
GRONINGEN 9727-DL NL
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Contact
BETTY IJMKER
Other 510(k) Applications for this Contact
Regulation Number
874.4780
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Classification Product Code
LYA
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More FDA Info for this Product Code
Date Received
05/30/2014
Decision Date
08/07/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
EN - Ear, Nose, & Throat
Review Advisory Committee
EN - Ear, Nose, & Throat
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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