Device Classification Name |
Keratome, Ac-Powered
|
510(k) Number |
K082043 |
Device Name |
CARRIAZO-PENDULAR MICROKERATOME |
Applicant |
SCHWIND EYE-TECH-SOLUTIONS GMBH & CO. KG |
MAINPARKSTRASSE 6-10 |
KLEINOSTHEIM,
DE
63801
|
|
Applicant Contact |
ROLF SCHWIND |
Correspondent |
TUV SUD AMERICA INC. |
1775 OLD HIGHWAY 8 NW |
NEW BRIGHTON,
MN
55112 -1891
|
|
Correspondent Contact |
STEFAN PREISS |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 07/18/2008 |
Decision Date | 08/01/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
|
|