Device Classification Name |
keratoscope, ac-powered
|
510(k) Number |
K944207 |
Device Name |
TOPOGRAPHIC MODELING SYSTEM 2 TMS-2 |
Applicant |
COMPUTED ANATOMY, INC. |
28 W. 36TH ST. |
NEW YORK,
NY
10018
|
|
Applicant Contact |
CHARLES J KLEIN |
Correspondent |
COMPUTED ANATOMY, INC. |
28 W. 36TH ST. |
NEW YORK,
NY
10018
|
|
Correspondent Contact |
CHARLES J KLEIN |
Regulation Number | 886.1350
|
Classification Product Code |
|
Date Received | 08/29/1994 |
Decision Date | 12/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|