Device Classification Name |
instrument, vitreous aspiration and cutting, ac-powered
|
510(k) Number |
K980488 |
Device Name |
STORZ MILLENNIUM MICROSURGICL SYSTEM HIGH SPEED VITRECTOMY SYSTEM |
Applicant |
STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. |
ST. LOUIS,
MO
63122 -6694
|
|
Applicant Contact |
GARY M RAUVOLA |
Correspondent |
STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. |
ST. LOUIS,
MO
63122 -6694
|
|
Correspondent Contact |
GARY M RAUVOLA |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 02/09/1998 |
Decision Date | 03/23/1998 |
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
|
|
|