FDA 510(k) Application Details - K974243

Device Classification Name	Keratome, Battery-Powered   More FDA Info for this Device
510(K) Number	K974243
Device Name	Keratome, Battery-Powered
Applicant	INSIGHT TECHNOLOGIES INSTRUMENTS, LLC. 16 HIGGINS DR. 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	11/12/1997
Decision Date	01/20/1998
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