Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K850900 |
Device Name |
PHACO-BAC STOP KIT |
Applicant |
STAAR SURGICAL CO. |
1911 WALKER AVE. |
MONROVIA,
CA
91016
|
|
Applicant Contact |
CALLAHAN |
Correspondent |
STAAR SURGICAL CO. |
1911 WALKER AVE. |
MONROVIA,
CA
91016
|
|
Correspondent Contact |
CALLAHAN |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 03/04/1985 |
Decision Date | 03/29/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|