The following data is part of a premarket notification filed by Renu Medical, Inc with the FDA for Reprocessed Tri Pulse Compression Garment.
| Device ID | K203847 |
| 510k Number | K203847 |
| Device Name: | Reprocessed Tri Pulse Compression Garment |
| Classification | Sleeve, Limb, Compressible |
| Applicant | RENU Medical, Inc 830 80th ST SW Suite 100 Everett, WA 98203 |
| Contact | Darren Demerritt |
| Correspondent | Darren Demerritt RENU Medical, Inc 830 80th ST SW Suite 100 Everett, WA 98203 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-31 |
| Decision Date | 2021-05-07 |