FDA 510(k) Application Details - K103409

Device Classification Name	Applicator, Absorbent Tipped, Non-Sterile   More FDA Info for this Device
510(K) Number	K103409
Device Name	Applicator, Absorbent Tipped, Non-Sterile
Applicant	SMARTPRACTICE 3400 EAST MCDOWLL ROAD PHOENIX, AZ 85008 US Other 510(k) Applications for this Company
Contact	KIM SULLIVAN Other 510(k) Applications for this Contact
Regulation Number	880.6025   More FDA Info for this Regulation Number
Classification Product Code	KXF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2010
Decision Date	03/15/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review