FDA 510(k) Application Details - K021569

Device Classification Name Device, Anti-Snoring

  More FDA Info for this Device
510(K) Number K021569
Device Name Device, Anti-Snoring
Applicant OTTAWA DENTAL LABORATORY
P.O. BOX 4341
CROFTON, MD 21114 US
Other 510(k) Applications for this Company
Contact E.J. Smith
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 05/14/2002
Decision Date 03/15/2004
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



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