FDA 510(k) Application Details - K965083

Device Classification Name Material, Impression

  More FDA Info for this Device
510(K) Number K965083
Device Name Material, Impression
Applicant S.S. WHITE MFG., LTD.
UNIT 9, MADLEAZE ESTATE
BRISTOL ROAD
GLOUCESTER GL1 5SG GB
Other 510(k) Applications for this Company
Contact HUGH SAVELL
Other 510(k) Applications for this Contact
Regulation Number 872.3660

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

  More FDA Info for this Product Code
Date Received 12/19/1996
Decision Date 04/04/1997
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