Device Classification Name |
needle, phacoemulsification, reprocessed
|
510(k) Number |
K030179 |
Device Name |
MEDISISS PHACOEMULSIFICATION TIPS/NEEDLES |
Applicant |
SURGICAL INSTRUMENTS SERVICE AND SAVINGS, INC. |
723 CURTIS CT; PO BOX 2060 |
SISTERS,
OR
97759
|
|
Applicant Contact |
MARY ANN BARKER |
Correspondent |
UNDERWRITERS LABORATORIES, INC. |
2600 NW LAKE RD. |
CAMAS,
WA
98607 -9526
|
|
Correspondent Contact |
CHARLES F MACK |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 01/17/2003 |
Decision Date | 01/24/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|