FDA 510(k) Application Details - K971078

Device Classification Name	Burr, Corneal, Ac-Powered   More FDA Info for this Device
510(K) Number	K971078
Device Name	Burr, Corneal, Ac-Powered
Applicant	MEDJET, INC. 1090 KING GEORGES POST, #301 EDISON, NJ 08837-3701 US Other 510(k) Applications for this Company
Contact	EUGENE GORDON Other 510(k) Applications for this Contact
Regulation Number	886.4070   More FDA Info for this Regulation Number
Classification Product Code	HQS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/24/1997
Decision Date	01/23/1998
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