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 |