FDA 510(k) Application Details - K132325

Device Classification Name	Barrier, Synthetic, Intraoral   More FDA Info for this Device
510(K) Number	K132325
Device Name	Barrier, Synthetic, Intraoral
Applicant	SUNSTAR AMERICAS, INC. 575 8TH AVE, STE 1212 NEW YORK, NY 10018 US Other 510(k) Applications for this Company
Contact	DEBORAH L GRAYESKI 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	07/26/2013
Decision Date	10/29/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review