FDA 510(k) Application Details - K013337

Device Classification Name	Keratome, Ac-Powered   More FDA Info for this Device
510(K) Number	K013337
Device Name	Keratome, Ac-Powered
Applicant	SURGIN INC 14762 BENTLEY CIRCLE TUSTIN, CA 92680 US Other 510(k) Applications for this Company
Contact	DON HAAR Other 510(k) Applications for this Contact
Regulation Number	886.4370   More FDA Info for this Regulation Number
Classification Product Code	HNO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/09/2001
Decision Date	12/13/2001
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