Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K951463 |
Device Name |
STORZ I/A HANDPIECES |
Applicant |
STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. |
ST. LOUIS,
MO
63122 -6694
|
|
Applicant Contact |
AUDREY G SWEARINGEN |
Correspondent |
STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. |
ST. LOUIS,
MO
63122 -6694
|
|
Correspondent Contact |
AUDREY G SWEARINGEN |
Regulation Number | 886.4670
|
Classification Product Code |
|
Date Received | 03/30/1995 |
Decision Date | 10/27/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|