FDA 510(k) Application Details - K151344

Device Classification Name	Barrier, Synthetic, Intraoral   More FDA Info for this Device
510(K) Number	K151344
Device Name	Barrier, Synthetic, Intraoral
Applicant	Unicare Biomedical, Inc. 23011 Moulton Parkway, J-11 Laguna Hills, CA 92653 US Other 510(k) Applications for this Company
Contact	Stan Yang 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	05/19/2015
Decision Date	11/19/2015
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