Device Classification Name |
Laser, Ophthalmic
|
510(k) Number |
K890086 |
Device Name |
MICROLASE 8 0 0 (OPHTHALMIC LASER) |
Applicant |
KEELER INSTRUMENTS, INC. |
456 PKWY. |
BROOMALL,
PA
19008
|
|
Applicant Contact |
VAN ARSDALE |
Correspondent |
KEELER INSTRUMENTS, INC. |
456 PKWY. |
BROOMALL,
PA
19008
|
|
Correspondent Contact |
VAN ARSDALE |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 01/10/1989 |
Decision Date | 03/15/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|