FDA 510(k) Application Details - K980816

Device Classification Name	Implant, Orbital, Extra-Ocular   More FDA Info for this Device
510(K) Number	K980816
Device Name	Implant, Orbital, Extra-Ocular
Applicant	FCI OPHTHALMICS, INC. P.O. BOX 465 76 PROSPECT ST. MARSHFIELD HILLS, MA 02051 US Other 510(k) Applications for this Company
Contact	ANNE BOHSACK Other 510(k) Applications for this Contact
Regulation Number	886.3340   More FDA Info for this Regulation Number
Classification Product Code	HQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/1998
Decision Date	09/18/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review