The following data is part of a premarket notification filed by Nanjing Maidixin Medical Device Co., Ltd. with the FDA for Endoscopic Linear Cutting Staplers With Single Use Loading Units.
| Device ID | K130738 |
| 510k Number | K130738 |
| Device Name: | ENDOSCOPIC LINEAR CUTTING STAPLERS WITH SINGLE USE LOADING UNITS |
| Classification | Staple, Implantable |
| Applicant | NANJING MAIDIXIN MEDICAL DEVICE CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong NANJING MAIDIXIN MEDICAL DEVICE 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 | 2013-03-18 |
| Decision Date | 2013-12-13 |
| Summary: | summary |