FDA 510(k) Application Details - K030809

Device Classification Name	Elastomer, Silicone Block   More FDA Info for this Device
510(K) Number	K030809
Device Name	Elastomer, Silicone Block
Applicant	HANSON MEDICAL, INC. 5662 CALLE REAL, #331 GOLETA, CA 93117 US Other 510(k) Applications for this Company
Contact	JOHN HARRISON Other 510(k) Applications for this Contact
Regulation Number	874.3620   More FDA Info for this Regulation Number
Classification Product Code	MIB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/2003
Decision Date	04/21/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review