The following data is part of a premarket notification filed by Changzhou Sinolinks Medical Innovation Co., Ltd with the FDA for Disposable Circular Stapler, Disposable Curved Cutter Stapler, Disposable Linear Staplers And Reloads, Disposable Hemorr.
| Device ID | K131511 |
| 510k Number | K131511 |
| Device Name: | DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CURVED CUTTER STAPLER, DISPOSABLE LINEAR STAPLERS AND RELOADS, DISPOSABLE HEMORR |
| Classification | Staple, Implantable |
| Applicant | CHANGZHOU SINOLINKS MEDICAL INNOVATION CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong CHANGZHOU SINOLINKS MEDICAL INNOVATION 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 | 2013-05-28 |
| Decision Date | 2013-07-05 |
| Summary: | summary |