FDA 510(k) Application Details - K010819

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K010819
Device Name	Syringe, Antistick
Applicant	NEW MEDICAL TECHNOLOGY LTD. 1500 WEST OAK ST. PO BOX 317 ZIONSVILLE, IN 46077 US Other 510(k) Applications for this Company
Contact	MIKE MALANDRAKIS Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	MEG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/19/2001
Decision Date	11/08/2001
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