Device Classification Name |
implant, eye sphere
|
510(k) Number |
K781356 |
Device Name |
IMPLANT, EYE SPHERE |
Applicant |
MCGHAN MEDICAL CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MCGHAN MEDICAL CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.3320
|
Classification Product Code |
|
Date Received | 08/07/1978 |
Decision Date | 08/21/1978 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|