FDA 510(k) Application Details - K964656

Device Classification Name	Barrier, Synthetic, Intraoral   More FDA Info for this Device
510(K) Number	K964656
Device Name	Barrier, Synthetic, Intraoral
Applicant	AMERICAN CUSTOM MEDICAL, INC. 2430 NORTH 7TH AVE., #4 BOZEMAN, MT 59715 US Other 510(k) Applications for this Company
Contact	BRUCE G RUEFER 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	11/20/1996
Decision Date	02/10/1997
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