FDA 510(k) Application Details - K981853

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K981853
Device Name	Needle, Hypodermic, Single Lumen
Applicant	WAISMED LTD. P.O.B. 454 GINOT SHOMRON 44853 IL Other 510(k) Applications for this Company
Contact	AHAVA STEIN Other 510(k) Applications for this Contact
Regulation Number	880.5570   More FDA Info for this Regulation Number
Classification Product Code	FMI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/1998
Decision Date	11/17/1998
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