Device Classification Name |
Unit, X-Ray, Extraoral With Timer
|
510(k) Number |
K122016 |
Device Name |
REXTAR, REXTAR LCD |
Applicant |
META BIOMED, INC. |
2600 MULLINIX MILL ROAD |
MT. AIRY,
MD
21771
|
|
Applicant Contact |
BLIX WINSTON |
Correspondent |
META BIOMED, INC. |
2600 MULLINIX MILL ROAD |
MT. AIRY,
MD
21771
|
|
Correspondent Contact |
BLIX WINSTON |
Regulation Number | 872.1800
|
Classification Product Code |
|
Date Received | 07/10/2012 |
Decision Date | 03/01/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|