FDA 510(k) Application Details - K981833

Device Classification Name	Prosthesis, Nose, Internal   More FDA Info for this Device
510(K) Number	K981833
Device Name	Prosthesis, Nose, Internal
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	878.3680   More FDA Info for this Regulation Number
Classification Product Code	FZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/1998
Decision Date	06/26/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review