FDA 510(k) Application Details - K974482

Device Classification Name	Elastomer, Silicone Block   More FDA Info for this Device
510(K) Number	K974482
Device Name	Elastomer, Silicone Block
Applicant	SILIMED, LLC. P.O BOX 4341 CROFTON, MD 21114 US Other 510(k) Applications for this Company
Contact	E J SMITH 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	11/26/1997
Decision Date	02/24/1998
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