The following data is part of a premarket notification filed by Ezisurg Medical Co.,ltd. with the FDA for Easyendo Linear Cutting Stapler And Loading Unit For Single Use(stapler;loading Unit).
| Device ID | K143129 |
| 510k Number | K143129 |
| Device Name: | EasyEndo Linear Cutting Stapler And Loading Unit For Single Use(Stapler;Loading Unit) |
| Classification | Staple, Implantable |
| Applicant | EziSurg Medical Co.,Ltd. Room 312, Bldg 2, No.1690 Cailun Road Zhangjiang High-Tech Park,Pudong Shanghai, CN 201203 |
| Contact | Johnny Yan |
| 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 | 2014-10-31 |
| Decision Date | 2015-01-29 |
| Summary: | summary |