FDA 510(k) Application Details - K043033

Device Classification Name	Ring, Teething, Fluid-Filled   More FDA Info for this Device
510(K) Number	K043033
Device Name	Ring, Teething, Fluid-Filled
Applicant	GLOBAL TREASURE INDUSTRIES LTD. 163 CABOT ST. BEVERLY, MA 01915 US Other 510(k) Applications for this Company
Contact	FRAN WHITE Other 510(k) Applications for this Contact
Regulation Number	872.5550   More FDA Info for this Regulation Number
Classification Product Code	KKO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/03/2004
Decision Date	03/22/2005
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