Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K934204 |
Device Name |
INTERTIP INFUSION SET |
Applicant |
OASIS MEDICAL, INC. |
514 S. VERMONT AVE. |
GLENDORA,
CA
91741
|
|
Applicant Contact |
NORMAN DELGADO |
Correspondent |
OASIS MEDICAL, INC. |
514 S. VERMONT AVE. |
GLENDORA,
CA
91741
|
|
Correspondent Contact |
NORMAN DELGADO |
Regulation Number | 886.4150
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/30/1993 |
Decision Date | 02/07/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|