FDA 510(k) Application Details - K041344

Device Classification Name	Syringe, Piston   More FDA Info for this Device
510(K) Number	K041344
Device Name	Syringe, Piston
Applicant	ISOTIS NV PROF. BRONKHORSTLAAN 10-D P.O. BOX 98,3723 AB BILTHOVEN 3723MB NL Other 510(k) Applications for this Company
Contact	ELIANE SCHUTTE Other 510(k) Applications for this Contact
Regulation Number	880.5860   More FDA Info for this Regulation Number
Classification Product Code	FMF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/2004
Decision Date	07/16/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review