Device Classification Name |
tonometer, manual
|
510(k) Number |
K022054 |
Device Name |
F 900 |
Applicant |
C.S.O. S.R.L. |
197 BELVOIR RD. |
WILLIAMSVILLE,
NY
14221
|
|
Applicant Contact |
R. BRENT MINER |
Correspondent |
C.S.O. S.R.L. |
197 BELVOIR RD. |
WILLIAMSVILLE,
NY
14221
|
|
Correspondent Contact |
R. BRENT MINER |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 06/24/2002 |
Decision Date | 08/06/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|