The following data is part of a premarket notification filed by Ezisurg (suzhou) Medical Co., Ltd. with the FDA for Linear Cutter Staplers And Loading Units For Single Use, Circular Staplers For Single Use.
| Device ID | K182217 |
| 510k Number | K182217 |
| Device Name: | Linear Cutter Staplers And Loading Units For Single Use, Circular Staplers For Single Use |
| Classification | Staple, Implantable |
| Applicant | Ezisurg (Suzhou) Medical Co., Ltd. Building 16, No.8 Jinfeng Rd. Suzhou National Hi-Tech District Suzhou, CN 215163 |
| Contact | Jingtian Ren |
| Correspondent | Ying Xu 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 | 2018-08-15 |
| Decision Date | 2019-04-16 |