FDA 510(k) Application Details - K052504

Device Classification Name	Elastomer, Silicone Block   More FDA Info for this Device
510(K) Number	K052504
Device Name	Elastomer, Silicone Block
Applicant	IMPLANTECH ASSOCIATES INC. 6025 NICOLLE ST., SUITE B VENTURA, CA 93003 US Other 510(k) Applications for this Company
Contact	STEPHEN MEADE 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	09/13/2005
Decision Date	11/04/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	EN - Ear, Nose, & Throat
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review