Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K954340 |
Device Name |
STORZ MICROFLOW PHACOEMULSIFICATION NEEDLE |
Applicant |
STORZ |
3365 TREE COURT INDUSTRIAL |
BOULEVARD |
ST. LOUIS,
MO
63122
|
|
Applicant Contact |
AUDREY SWEARINGEN |
Correspondent |
STORZ |
3365 TREE COURT INDUSTRIAL |
BOULEVARD |
ST. LOUIS,
MO
63122
|
|
Correspondent Contact |
AUDREY SWEARINGEN |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 09/18/1995 |
Decision Date | 12/14/1995 |
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
|
|
|