Device Classification Name |
folders and injectors, intraocular lens (iol)
|
510(k) Number |
K980696 |
Device Name |
FOAM TIP INJECTOR |
Applicant |
STAAR SURGICAL CO. |
1911 WALKER AVE. |
MONROVIA,
CA
91016
|
|
Applicant Contact |
JANICE L FILIPPELLI |
Correspondent |
STAAR SURGICAL CO. |
1911 WALKER AVE. |
MONROVIA,
CA
91016
|
|
Correspondent Contact |
JANICE L FILIPPELLI |
Regulation Number | 886.4300
|
Classification Product Code |
|
Date Received | 02/23/1998 |
Decision Date | 09/11/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|