The following data is part of a premarket notification filed by Jingzhou Haixin Green Cross Medical Products Co., Ltd with the FDA for Surgical Isolation Gown.
| Device ID | K171535 |
| 510k Number | K171535 |
| Device Name: | SURGICAL ISOLATION GOWN |
| Classification | Gown, Isolation, Surgical |
| Applicant | Jingzhou Haixin Green Cross Medical Products Co., Ltd Room 916-918, Floor 9, International Finance Center No.296, Xinhua Road Wuhan, CN 430015 |
| Contact | Rarda L |
| Correspondent | Raymond Luo Shanghai Sungo Management Consulting Company Limited 4th Floor, 1500# Central Avenue Shanghai, CN 200122 |
| Product Code | FYC |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-25 |
| Decision Date | 2018-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00097604945400 | K171535 | 000 |
| 00097604945356 | K171535 | 000 |
| 00097604945257 | K171535 | 000 |