Device Classification Name |
dilator, vessel, surgical
|
510(k) Number |
K183438 |
Device Name |
Geomed Vascular Dilators |
Applicant |
Geomed Medizin-Technik GmbH & Co. |
Ludwigstaler Strasse 27 |
Tuttlingen,
DE
78532
|
|
Applicant Contact |
Hanno Haug |
Correspondent |
Business Support International |
Amstel 320-1 |
Amsterdam,
NL
1017AP
|
|
Correspondent Contact |
Angelika Scherp |
Regulation Number | 870.4475
|
Classification Product Code |
|
Date Received | 12/12/2018 |
Decision Date | 09/03/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|