FDA 510(k) Application Details - K992553

Device Classification Name	Applicator, Absorbent Tipped, Non-Sterile   More FDA Info for this Device
510(K) Number	K992553
Device Name	Applicator, Absorbent Tipped, Non-Sterile
Applicant	DORMER LABORATORIES, INC. 2000 M. ST., N.W., 7TH FLOOR WASHINGTON, DC 20036-3307 US Other 510(k) Applications for this Company
Contact	DANIEL MANELLI 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	07/30/1999
Decision Date	04/12/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review