FDA 510(k) Application Details - K972225

Device Classification Name	Light, Surgical, Fiberoptic   More FDA Info for this Device
510(K) Number	K972225
Device Name	Light, Surgical, Fiberoptic
Applicant	UNIVERSAL FIBEROPTIC REPAIR, INC. 9 WRIGHTS CROSSING POMFRET CENTER, CT 06259 US Other 510(k) Applications for this Company
Contact	DEREK N MAY Other 510(k) Applications for this Contact
Regulation Number	878.4580   More FDA Info for this Regulation Number
Classification Product Code	FST Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/13/1997
Decision Date	03/18/1998
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