The following data is part of a premarket notification filed by Radial Medical, Inc. with the FDA for Radial Medical Compression System.
| Device ID | K190976 |
| 510k Number | K190976 |
| Device Name: | Radial Medical Compression System |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Radial Medical, Inc. 2500 Grant Road Mountain View, CA 94040 |
| Contact | Eric Johnson |
| Correspondent | Mark Smutka Mark Smutka 10984 Northseal Square Cupertino, CA 95014 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-04-15 |
| Decision Date | 2019-07-12 |