FDA 510(k) Application Details - K971480

Device Classification Name	Elastomer, Silicone Block   More FDA Info for this Device
510(K) Number	K971480
Device Name	Elastomer, Silicone Block
Applicant	ALLIED BIOMEDICAL CORP. 3850 RAMADA DR., SUITE C-2 PASO ROBLES, CA 93446 US Other 510(k) Applications for this Company
Contact	GERALD HANSON 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	04/23/1997
Decision Date	05/28/1997
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