Device Classification Name |
Diagnostic Light, Soft Tissue Detector
|
510(k) Number |
K090135 |
Device Name |
TRIMIRA IDENTAFI 3000 |
Applicant |
REMICALM, LLC |
952 ECHO LANE, SUITE 333 |
HOUSTON,
TX
77024 -2758
|
|
Applicant Contact |
DAVID B JONES |
Correspondent |
REMICALM, LLC |
952 ECHO LANE, SUITE 333 |
HOUSTON,
TX
77024 -2758
|
|
Correspondent Contact |
DAVID B JONES |
Regulation Number | 872.6350
|
Classification Product Code |
|
Date Received | 01/21/2009 |
Decision Date | 02/17/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|