FDA 510(k) Application Details - K022627

Device Classification Name Mouthguard, Prescription

  More FDA Info for this Device
510(K) Number K022627
Device Name Mouthguard, Prescription
Applicant SENTAGE CORPORATION D/B/A/ DENTAL SERVICES GROUP
1801 K ST. NW
SUITE 1200
WASHINGTON, DC 20006 US
Other 510(k) Applications for this Company
Contact G. BRENT CONNOR
Other 510(k) Applications for this Contact
Regulation Number 000.0000

  More FDA Info for this Regulation Number
Classification Product Code MQC
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 08/07/2002
Decision Date 03/18/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K022627


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