FDA 510(k) Application Details - K012142

Device Classification Name	Device, Anti-Snoring   More FDA Info for this Device
510(K) Number	K012142
Device Name	Device, Anti-Snoring
Applicant	PRECISION DENTAL LABORATORIES, INC. 6 BROADWAY SUITE 200 FARGO, ND 58102 US Other 510(k) Applications for this Company
Contact	SHARON LAMONT Other 510(k) Applications for this Contact
Regulation Number	872.5570   More FDA Info for this Regulation Number
Classification Product Code	LRK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/2001
Decision Date	10/04/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review