FDA 510(k) Application Details - K981852

Device Classification Name	Expander, Skin, Inflatable   More FDA Info for this Device
510(K) Number	K981852
Device Name	Expander, Skin, Inflatable
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	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/1998
Decision Date	08/05/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review