FDA 510(k) Application Details - K962680

Device Classification Name Material, Impression

  More FDA Info for this Device
510(K) Number K962680
Device Name Material, Impression
Applicant HYUNJAE CORP.
8 SOUTH END PLAZA
NEW MILFORD, CT 06776 US
Other 510(k) Applications for this Company
Contact DANIEL G MODICA
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 07/10/1996
Decision Date 09/30/1996
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