FDA 510(k) Application Details - K081816

Device Classification Name	System, Vocal Cord Medialization   More FDA Info for this Device
510(K) Number	K081816
Device Name	System, Vocal Cord Medialization
Applicant	CYTOPHIL INC 5546 N SANTA MONICA BLVD WHITEFISH BAY, WI 53217-5159 US Other 510(k) Applications for this Company
Contact	Greg Johnson 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	06/26/2008
Decision Date	01/05/2009
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