The following data is part of a premarket notification filed by Getinge (suzhou) Co., Ltd. with the FDA for Flowtron Dvt5 Small Calf Garment.
| Device ID | K172103 |
| 510k Number | K172103 |
| Device Name: | Flowtron DVT5 Small Calf Garment |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Getinge (Suzhou) Co., Ltd. No. 158 Fangzhou Road Suzhou, CN 2015024 |
| Contact | Daisy Qin |
| Correspondent | David Moynham ArjoHuntleigh AB 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 | 2017-07-12 |
| Decision Date | 2018-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055982786348 | K172103 | 000 |