FDA 510(k) Application Details - K984187

Device Classification Name	Gauze/Sponge, Internal   More FDA Info for this Device
510(K) Number	K984187
Device Name	Gauze/Sponge, Internal
Applicant	CROSSTEX INTL. 55 NORTHERN BLVD., SUITE 410 GREAT NECK, NY 11021 US Other 510(k) Applications for this Company
Contact	SUSAN D GOLDSTEIN-FALK Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	EFQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/23/1998
Decision Date	02/18/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review