Device Classification Name |
Tonometer, Manual
|
510(k) Number |
K992835 |
Device Name |
C.S.O. TONOMETER |
Applicant |
CSO |
197 BELVOIR RD. |
WILLIAMSVILLE,
NY
14221
|
|
Applicant Contact |
R. BRENT MINER |
Correspondent |
CSO |
197 BELVOIR RD. |
WILLIAMSVILLE,
NY
14221
|
|
Correspondent Contact |
R. BRENT MINER |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 08/23/1999 |
Decision Date | 06/06/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|