FDA 510(k) Application Details - K150400

Device Classification Name	System, Vocal Cord Medialization   More FDA Info for this Device
510(K) Number	K150400
Device Name	System, Vocal Cord Medialization
Applicant	CYTOPHIL, INC. 2485 CORPORATE CIRCLE SUITE 2 EAST TROY, WI 53120 US Other 510(k) Applications for this Company
Contact	BOB VOIGTS Other 510(k) Applications for this Contact
Regulation Number	874.3620   More FDA Info for this Regulation Number
Classification Product Code	MIX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2015
Decision Date	04/06/2015
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