Device Classification Name |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered
|
510(k) Number |
K964743 |
Device Name |
STORZ E8010 ERGOTEC/PREMIERE ADAPTOR |
Applicant |
STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. |
ST. LOUIS,
MO
63122 -6694
|
|
Applicant Contact |
PATRICK G BALSMANN |
Correspondent |
STORZ INSTRUMENT CO. |
3365 TREE CT. INDUSTRIAL BLVD. |
ST. LOUIS,
MO
63122 -6694
|
|
Correspondent Contact |
PATRICK G BALSMANN |
Regulation Number | 886.4150
|
Classification Product Code |
|
Date Received | 11/26/1996 |
Decision Date | 02/03/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|