Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K771711 |
Device Name |
BIOTOME |
Applicant |
BERKELEY BIO-ENGINEERING |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
BERKELEY BIO-ENGINEERING |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 09/12/1977 |
Decision Date | 09/28/1977 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|