FDA 510(k) Application Details - K950806

Device Classification Name	Implant, Orbital, Extra-Ocular   More FDA Info for this Device
510(K) Number	K950806
Device Name	Implant, Orbital, Extra-Ocular
Applicant	MIRA, INC. 414 QUAKER HWY. UXBRIDGE, MA 01569 US Other 510(k) Applications for this Company
Contact	ROSINA ROBINSON 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	02/22/1995
Decision Date	06/05/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review