FDA 510(k) Application Details - K971487

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K971487
Device Name	Needle, Hypodermic, Single Lumen
Applicant	SUMI SALUD C.A. P.O. BOX 296 FRONT ROYAL, VA 22630 US Other 510(k) Applications for this Company
Contact	SUZANNE PARISIAN 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	04/23/1997
Decision Date	09/04/1997
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