Device Classification Name |
Lens, Guide, Intraocular
|
510(k) Number |
K940593 |
Device Name |
DISPOSABLE MICROSTAAR INJECTOR |
Applicant |
STAAR SUGICAL |
1911 WALKER AVE. |
MONROVIA,
CA
91016
|
|
Applicant Contact |
STEVEN L ZIEMBA |
Correspondent |
STAAR SUGICAL |
1911 WALKER AVE. |
MONROVIA,
CA
91016
|
|
Correspondent Contact |
STEVEN L ZIEMBA |
Regulation Number | 886.4300
|
Classification Product Code |
|
Date Received | 02/09/1994 |
Decision Date | 09/19/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|