FDA 510(k) Application Details - K112093

Device Classification Name	Unit, Cryophthalmic, Ac-Powered   More FDA Info for this Device
510(K) Number	K112093
Device Name	Unit, Cryophthalmic, Ac-Powered
Applicant	KEELER INSTRUMENTS, INC. 456 PKWY. BROOMALL, PA 19008 US Other 510(k) Applications for this Company
Contact	EUGENE R VANARSDALE Other 510(k) Applications for this Contact
Regulation Number	886.4170   More FDA Info for this Regulation Number
Classification Product Code	HRN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/22/2011
Decision Date	12/08/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review