The following data is part of a premarket notification filed by Chongqing Qmi Surgical Co., Ltd with the FDA for Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler And Single Use Loading Unit; Linear Cutting Stapler And Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler.
| Device ID | K162947 |
| 510k Number | K162947 |
| Device Name: | Disposable End-to-end Anastomosis Circular Stapler; Universal Endoscopic Linear Cutting Stapler And Single Use Loading Unit; Linear Cutting Stapler And Single Use Loading Unit; Disposal Hemorrhoidal Circular Stapler |
| Classification | Staple, Implantable |
| Applicant | CHONGQING QMI SURGICAL CO., LTD A ZONE 1ST FLOOR, YANGLIU ROAD NO.2 NORTH NEW ZONE Chongqing, CN 401121 |
| Contact | Kang Li |
| 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 | 2016-10-21 |
| Decision Date | 2017-03-03 |
| Summary: | summary |