The following data is part of a premarket notification filed by Shenzhen Homed Medical Device Co,.ltd. with the FDA for Homed Mesh Nebulizer.
| Device ID | K170886 |
| 510k Number | K170886 |
| Device Name: | HOMED Mesh Nebulizer |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Shenzhen Homed Medical Device Co,.Ltd. 3rd Floor, Block 2, Longgu Industrial Zone, Huawang Road Tongsheng Community, Dalang Street, Longhua New District Shenzhen, CN 518109 |
| Contact | Shengming Shi |
| Correspondent | Shengming Shi Shenzhen Homed Medical Device Co,.Ltd. 3rd Floor, Block 2, Longgu Industrial Zone, Huawang Road Tongsheng Community, Dalang Street, Longhua New District Shenzhen, CN 518109 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-27 |
| Decision Date | 2018-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06956937001457 | K170886 | 000 |
| 00850022699115 | K170886 | 000 |