FDA 510(k) Application Details - K000252

Device Classification Name	Endoilluminator   More FDA Info for this Device
510(K) Number	K000252
Device Name	Endoilluminator
Applicant	INSIGHT INSTRUMENTS MFG., INC. 5400 SOUTH BRYANT AVE. SANFORD, FL 32773 US Other 510(k) Applications for this Company
Contact	K. PETER LULOH Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	MPA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/27/2000
Decision Date	10/17/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review