Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K212241 |
Device Name |
QUATERA 700 |
Applicant |
Carl Zeiss Meditec AG |
Goeschwitzer Strasse 51-52 |
Jena,
DE
07745
|
|
Applicant Contact |
Hans-Joachim Miesner |
Correspondent |
Carl Zeiss Meditec Inc |
5300 Central Parkway |
Dublin,
CA
94568
|
|
Correspondent Contact |
Maria Golovina |
Regulation Number | 886.4670
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/19/2021 |
Decision Date | 04/19/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|