| Device Classification Name |
X-Ray, Tomography, Computed, Dental
More FDA Info for this Device |
| 510(K) Number |
K003787 |
| Device Name |
X-Ray, Tomography, Computed, Dental |
| Applicant |
APERIO SERVICES, LLC
815 CONNECTICUT AVENUE, NW
WASHINGTON,, DC 20006-4078 US
Other 510(k) Applications for this Company
|
| Contact |
GREGORY W BOWMAN
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 |
12/08/2000 |
| Decision Date |
03/08/2001 |
| 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 |
|