The following data is part of a premarket notification filed by Changzhou Kangdi Medical Stapler Co., Ltd. with the FDA for Disposable Circular Stapler, Disposable Circular Stapler Model Kygw-25.5, Kygw-28.5.
| Device ID | K100723 |
| 510k Number | K100723 |
| Device Name: | DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5 |
| Classification | Staple, Implantable |
| Applicant | CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-15 |
| Decision Date | 2010-04-30 |
| Summary: | summary |