FDA 510(k) Application Details - K981266

Device Classification Name	Introducer, Syringe Needle   More FDA Info for this Device
510(K) Number	K981266
Device Name	Introducer, Syringe Needle
Applicant	MIGHTY MO, CORP. 150 2ND AVE NORH SUITE 920 ST. PETERSBURG, FL 33701 US Other 510(k) Applications for this Company
Contact	JOHN D'ANGELO Other 510(k) Applications for this Contact
Regulation Number	880.6920   More FDA Info for this Regulation Number
Classification Product Code	KZH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/07/1998
Decision Date	07/14/1998
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