Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Battery-Powered
|
510(k) Number |
K791898 |
Device Name |
OCUTOME MODEL 8000 |
Applicant |
COOPER MEDICAL DEVICES CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
COOPER MEDICAL DEVICES CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 09/25/1979 |
Decision Date | 10/30/1979 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|