FDA 510(k) Application Details - K052513

Device Classification Name	Ring, Teething, Fluid-Filled   More FDA Info for this Device
510(K) Number	K052513
Device Name	Ring, Teething, Fluid-Filled
Applicant	DELTA ENTERPRISE CORPORATION 17 STATE STREET, 19TH FLOOR NEW YORK, NY 10004 US Other 510(k) Applications for this Company
Contact	MARIA E CELIS 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	09/14/2005
Decision Date	06/28/2006
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