FDA 510(k) Application Details - K011554

Device Classification Name	System, Vocal Cord Medialization   More FDA Info for this Device
510(K) Number	K011554
Device Name	System, Vocal Cord Medialization
Applicant	BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK WARSAW, IN 46581-0587 US Other 510(k) Applications for this Company
Contact	PATRICIA SANDBORN BERES 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	05/18/2001
Decision Date	06/26/2001
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