FDA 510(k) Application Details - K033074

Device Classification Name	Barrier, Synthetic, Intraoral   More FDA Info for this Device
510(K) Number	K033074
Device Name	Barrier, Synthetic, Intraoral
Applicant	INION LTD. LAAKARINKATU 2 TAMPERE 33520 FI Other 510(k) Applications for this Company
Contact	HANNA MARTTILA Other 510(k) Applications for this Contact
Regulation Number	872.3930   More FDA Info for this Regulation Number
Classification Product Code	NPK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2003
Decision Date	03/31/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review