The following data is part of a premarket notification filed by Slk Medical Gmbh with the FDA for Varilymph 12 Pro.
| Device ID | K193476 |
| 510k Number | K193476 |
| Device Name: | VariLymph 12 Pro |
| Classification | Sleeve, Limb, Compressible |
| Applicant | SLK Medical GmbH Oberste-Wilms-Str. 15a Dortmund, DE 44309 |
| Contact | Matthew Reid |
| Correspondent | Matthew Reid SLK Medical GmbH Oberste-Wilms-Str. 15a Dortmund, DE 44309 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-16 |
| Decision Date | 2020-08-19 |