The following data is part of a premarket notification filed by Geomed Medizin-technik Gmbh & Co. Kg with the FDA for Assisto Universal Applicator Clamping Device.
| Device ID | K201279 |
| 510k Number | K201279 |
| Device Name: | ASSISTO Universal Applicator Clamping Device |
| Classification | System, Applicator, Radionuclide, Remote-controlled |
| Applicant | Geomed Medizin-Technik GmbH & Co. KG Ludwigstaler Strasse 27 Tuttlingen, DE 78532 |
| Contact | Hanno Haug |
| Correspondent | Angelika Scherp Business Support International Aalsmeerweg 123-3 Amsterdam, NL 1059ah |
| Product Code | JAQ |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | GWG |
| CFR Regulation Number | 892.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-13 |
| Decision Date | 2020-07-10 |