The following data is part of a premarket notification filed by Saalmann Medical Gmbh & Co. Kg with the FDA for Saalio.
| Device ID | K191436 |
| 510k Number | K191436 |
| Device Name: | Saalio |
| Classification | Device, Iontophoresis, Other Uses |
| Applicant | Saalmann Medical GmbH & Co. KG Sudbahnstrabe 34 Bad Oeynhausen, DE 32547 |
| Contact | Rolf Eilers |
| Correspondent | Michael Vent BEO MedConsulting Berlin GmbH Helmholtzstr. 2 Berlin, DE 10587 |
| Product Code | EGJ |
| CFR Regulation Number | 890.5525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-30 |
| Decision Date | 2019-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260587510200 | K191436 | 000 |