Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K896754 |
Device Name |
I/A HANDPIECE |
Applicant |
ADVANCED SURGICAL PRODUCTS, INC. |
750 GODDARD AVE. |
CHESTERFIELD,
MO
63005
|
|
Applicant Contact |
JAMES C EASLEY |
Correspondent |
ADVANCED SURGICAL PRODUCTS, INC. |
750 GODDARD AVE. |
CHESTERFIELD,
MO
63005
|
|
Correspondent Contact |
JAMES C EASLEY |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 11/30/1989 |
Decision Date | 01/11/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|