FDA 510(k) Application Details - K974653

Device Classification Name	Elastomer, Silicone Block   More FDA Info for this Device
510(K) Number	K974653
Device Name	Elastomer, Silicone Block
Applicant	SPECIALTY SURGICAL PRODUCTS, INC. 302 NORTH FIRST ST. HAMILTON, MT 59840 US Other 510(k) Applications for this Company
Contact	T. JAN VARNER 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	12/15/1997
Decision Date	03/13/1998
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