FDA 510(k) Application Details - K973339

Device Classification Name	Needle, Hypodermic, Single Lumen   More FDA Info for this Device
510(K) Number	K973339
Device Name	Needle, Hypodermic, Single Lumen
Applicant	DISETRONIC MEDICAL SYSTEMS 7690 CAMERON CIRCLE FT. MEYERS, FL 33912 US Other 510(k) Applications for this Company
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	09/05/1997
Decision Date	09/24/1997
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