The following data is part of a premarket notification filed by Geomed Medizin-technik Gmbh & Co. with the FDA for Geomed Vascular Dilators.
| Device ID | K183438 |
| 510k Number | K183438 |
| Device Name: | Geomed Vascular Dilators |
| Classification | Dilator, Vessel, Surgical |
| Applicant | Geomed Medizin-Technik GmbH & Co. Ludwigstaler Strasse 27 Tuttlingen, DE 78532 |
| Contact | Hanno Haug |
| Correspondent | Angelika Scherp Business Support International Amstel 320-1 Amsterdam, NL 1017ap |
| Product Code | DWP |
| CFR Regulation Number | 870.4475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-12 |
| Decision Date | 2019-09-03 |
| Summary: | summary |