FDA 510(k) Application Details - K984537

Device Classification Name	Keratome, Battery-Powered   More FDA Info for this Device
510(K) Number	K984537
Device Name	Keratome, Battery-Powered
Applicant	INSIGHT TECHNOLOGIES INSTRUMENTS, LLC. 264 QUARRY RD. MILFORD, CT 06460 US Other 510(k) Applications for this Company
Contact	CHARLES VASSALLO Other 510(k) Applications for this Contact
Regulation Number	886.4370   More FDA Info for this Regulation Number
Classification Product Code	HMY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/1998
Decision Date	05/14/1999
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