The following data is part of a premarket notification filed by Ezisurg Medical Co., Ltd. with the FDA for Easypphtm Hemorrhoidal Stapler For Single Use.
| Device ID | K183477 |
| 510k Number | K183477 |
| Device Name: | EasyPPHTM Hemorrhoidal Stapler For Single Use |
| Classification | Staple, Implantable |
| Applicant | Ezisurg Medical Co., Ltd. Rm.103, Bldg.2, No.1690 Cailun Rd. China(Shanghai) Pilot Free Trade Zone Shanghai, CN 201203 |
| Contact | Liang Xia |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-17 |
| Decision Date | 2019-02-11 |
| Summary: | summary |