FDA 510(k) Application Details - K984029

Device Classification Name	Elastomer, Silicone, For Scar Management   More FDA Info for this Device
510(K) Number	K984029
Device Name	Elastomer, Silicone, For Scar Management
Applicant	NAGOR LTD. PO BOX 21 DOUGLAS ISLE OF MAN IM99 1AX BRITISH ISLES VG Other 510(k) Applications for this Company
Contact	J.A. EVANS Other 510(k) Applications for this Contact
Regulation Number	878.4025   More FDA Info for this Regulation Number
Classification Product Code	MDA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/1998
Decision Date	08/05/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review