Device Classification Name |
instrument, vitreous aspiration and cutting, ac-powered
|
510(k) Number |
K813274 |
Device Name |
BLOOD POOL & SUBVETINAL FLUID ASPIRATOR |
Applicant |
OPTICAL MICRO SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
OPTICAL MICRO SYSTEMS, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 11/23/1981 |
Decision Date | 02/05/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|