Device Classification Name |
Tonometer, Manual
|
510(k) Number |
K152644 |
Device Name |
KEELER DISPOSABLE TONOMATE, KEELER DISPOSABLE TONOMATE, BOX OF 100 |
Applicant |
KEELER LIMITED |
CLEWER HILL ROAD |
WINDSOR,
GB
SL4 4AA
|
|
Applicant Contact |
IRINA PROUTSKI |
Correspondent |
KEELER INSTRUMENTS, INC. |
456 PARKWAY |
BROOMALL,
PA
19008
|
|
Correspondent Contact |
EUGENE R. VAN ARSDALE |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 09/16/2015 |
Decision Date | 12/31/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|