Device Classification Name |
microscope, operating & accessories, ac-powered, ophthalmic
|
510(k) Number |
K844323 |
Device Name |
KONAN CLINIC MICROSCOPE CLM-100-150 |
Applicant |
KEELER INSTRUMENTS, INC. |
456 PKWY. |
BROOMALL,
PA
19008
|
|
Applicant Contact |
VAN ARSDAL |
Correspondent |
KEELER INSTRUMENTS, INC. |
456 PKWY. |
BROOMALL,
PA
19008
|
|
Correspondent Contact |
VAN ARSDAL |
Regulation Number | 878.4700
|
Classification Product Code |
|
Date Received | 11/07/1984 |
Decision Date | 11/21/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|