FDA 510(k) Application Details - K021839

Device Classification Name	Elastomer, Silicone Block   More FDA Info for this Device
510(K) Number	K021839
Device Name	Elastomer, Silicone Block
Applicant	AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. 5871 LONE PINE PLACE PASO ROBLES, CA 93446 US Other 510(k) Applications for this Company
Contact	CATHERINE RIPLE 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	06/04/2002
Decision Date	07/16/2002
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