FDA 510(k) Application Details - K160102

Device Classification Name Powder, Porcelain

  More FDA Info for this Device
510(K) Number K160102
Device Name Powder, Porcelain
Applicant HASS CORP.
77-14, GWAHAKDANJI-RO
GANGNEUNG-SI 210-340 KR
Other 510(k) Applications for this Company
Contact YONGSU KIM
Other 510(k) Applications for this Contact
Regulation Number 872.6660

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

  More FDA Info for this Product Code
Date Received 01/19/2016
Decision Date 07/14/2016
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