Device Classification Name |
biomicroscope, slit-lamp, ac-powered
|
510(k) Number |
K973064 |
Device Name |
KEELER TEARSCOPE-PLUS |
Applicant |
KEELER INSTRUMENTS, INC. |
456 PKWY. |
BROOMALL,
PA
19008
|
|
Applicant Contact |
EUGENE R VAN ARSDALE |
Correspondent |
KEELER INSTRUMENTS, INC. |
456 PKWY. |
BROOMALL,
PA
19008
|
|
Correspondent Contact |
EUGENE R VAN ARSDALE |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 08/18/1997 |
Decision Date | 04/07/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|