Device Classification Name |
unit, cryophthalmic
|
510(k) Number |
K873388 |
Device Name |
KEELER CTU CRYO SYSTEM |
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 | 886.4170
|
Classification Product Code |
|
Date Received | 08/24/1987 |
Decision Date | 11/13/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|