Device Classification Name |
Unit, X-Ray, Extraoral With Timer
More FDA Info for this Device |
510(K) Number |
K192700 |
Device Name |
Unit, X-Ray, Extraoral With Timer |
Applicant |
HDX WILL Corp.
#105,106,201,202,203,204,38,Osongsaengmyeong-4-ro
Osong-eup,Heungdeok-gu
Cheongju-si 28161 KR
Other 510(k) Applications for this Company
|
Contact |
Myoung-Joon Lee
Other 510(k) Applications for this Contact |
Regulation Number |
872.1800
More FDA Info for this Regulation Number |
Classification Product Code |
EHD
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
09/26/2019 |
Decision Date |
12/27/2019 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
DE - Dental |
Review Advisory Committee |
RA - Radiology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|