FDA 510(k) Application Details - K033398

Device Classification Name	System, Vocal Cord Medialization   More FDA Info for this Device
510(K) Number	K033398
Device Name	System, Vocal Cord Medialization
Applicant	BIOFORM, INC. 1875 SOUTH GRANT ST.,SUITE 11O SAN MATEO, CA 94402 US Other 510(k) Applications for this Company
Contact	JAMES MILLER 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	10/24/2003
Decision Date	12/12/2003
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