FDA 510(k) Application Details - K123184

Device Classification Name	Applicator, Absorbent Tipped, Non-Sterile   More FDA Info for this Device
510(K) Number	K123184
Device Name	Applicator, Absorbent Tipped, Non-Sterile
Applicant	SMART PRACTICE 3400 EAST MCDOWELL RD. 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	10/10/2012
Decision Date	12/19/2012
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