FDA 510(k) Application Details - K110734

Device Classification Name	More FDA Info for this Device
510(K) Number	K110734
Device Name	NCI SPATULA
Applicant	FISCHER SURGICAL INC. 1012 PALMER LANE, SUITE 200 IMPERIAL, MO 63052 US Other 510(k) Applications for this Company
Contact	JESSICA DIXON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/16/2011
Decision Date	05/31/2012
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