Device Classification Name |
X-Ray, Tomography, Computed, Dental
More FDA Info for this Device |
510(K) Number |
K160140 |
Device Name |
X-Ray, Tomography, Computed, Dental |
Applicant |
HDX WILL CORP.
#105, 201, 202, 203, 204, 38
OSONGSAENGMYEONG 4-RO, OSONG-EUP HEUNGDEOK-GU
Cheongju-si 28161 KR
Other 510(k) Applications for this Company
|
Contact |
Hyung-suk Oh
Other 510(k) Applications for this Contact |
Regulation Number |
892.1750
More FDA Info for this Regulation Number |
Classification Product Code |
OAS
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
01/21/2016 |
Decision Date |
09/30/2016 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
RA - Radiology |
Review Advisory Committee |
RA - Radiology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|