FDA 510(k) Application Details - K003348

Device Classification Name	Syringe, Antistick   More FDA Info for this Device
510(K) Number	K003348
Device Name	Syringe, Antistick
Applicant	ENSI-MED INTERNATIONAL PTY. LTD. 19-21 PENINSULA BLVD. SEAFORD, VICTORIA 3198 AU Other 510(k) Applications for this Company
Contact	NAP CURIE 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	10/26/2000
Decision Date	01/12/2001
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