FDA 510(k) Application Details - K080514

Device Classification Name Material, Impression

  More FDA Info for this Device
510(K) Number K080514
Device Name Material, Impression
Applicant 3M ESPE AG DENTAL PRODUCTS
ESPE PLATZ
SEEFELD, BAVARIA D-82229 DE
Other 510(k) Applications for this Company
Contact DESI W SOEGIARTO
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 02/25/2008
Decision Date 03/26/2008
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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