FDA 510(k) Application Details - K041580

Device Classification Name System,X-Ray,Extraoral Source,Digital

  More FDA Info for this Device
510(K) Number K041580
Device Name System,X-Ray,Extraoral Source,Digital
Applicant HENRY SCHEIN, INC.
11661 SAN VICENTE BOULEVARD
LOS ANGELES, CA 90049 US
Other 510(k) Applications for this Company
Contact W. EDWARD JOHANSEN
Other 510(k) Applications for this Contact
Regulation Number 872.1800

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

  More FDA Info for this Product Code
Date Received 06/14/2004
Decision Date 06/29/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party Y
Expedited Review



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