FDA 510(k) Application Details - K003382

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K003382
Device Name	Needle, Hypodermic, Single Lumen
Applicant	SARSTEDT, INC. 1025 ST. JAMES CHURCH RD. PO BOX 468 NEWTON, NC 28658 US Other 510(k) Applications for this Company
Contact	PETER RUMSWINKEL 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	10/31/2000
Decision Date	03/30/2001
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