The following data is part of a premarket notification filed by Huntleigh Healthcare Ltd with the FDA for Hydroven 12, Hydroven 12 Garments.
| Device ID | K152228 |
| 510k Number | K152228 |
| Device Name: | Hydroven 12, Hydroven 12 Garments |
| Classification | Sleeve, Limb, Compressible |
| Applicant | HUNTLEIGH HEALTHCARE LTD 35 PORTMANMOOR ROAD Cardiff, GB Cf24 5hn |
| Contact | Greg Baily |
| Correspondent | Greg Baily HUNTLEIGH HEALTHCARE LTD 35 PORTMANMOOR ROAD Cardiff, GB Cf24 5hn |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-07 |
| Decision Date | 2016-04-04 |
| Summary: | summary |