FDA 510(k) Application Details - K141816

Device Classification Name	Splint, Intranasal Septal   More FDA Info for this Device
510(K) Number	K141816
Device Name	Splint, Intranasal Septal
Applicant	Polyganics BV ROZENBURGLAAN 15A GRONINGEN 9727DL NL Other 510(k) Applications for this Company
Contact	BETTY IJMKER Other 510(k) Applications for this Contact
Regulation Number	874.4780   More FDA Info for this Regulation Number
Classification Product Code	LYA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2014
Decision Date	10/23/2014
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