FDA 510(k) Application Details - K013808

Device Classification Name Device, Anti-Snoring

  More FDA Info for this Device
510(K) Number K013808
Device Name Device, Anti-Snoring
Applicant DENTAL IMAGINEERS, LLC.
804 WEST PARK AVE.
OCEAN, NJ 07712 US
Other 510(k) Applications for this Company
Contact WILLIAM A BELFER
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 11/15/2001
Decision Date 01/30/2002
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact