The following data is part of a premarket notification filed by Changzhou Kangdi Medical Stapler Co., Ltd. with the FDA for Disposable Linear Stapler, Disposable Linear Cutter.
| Device ID | K121474 |
| 510k Number | K121474 |
| Device Name: | DISPOSABLE LINEAR STAPLER, DISPOSABLE LINEAR CUTTER |
| Classification | Staple, Implantable |
| Applicant | CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. 77325 JOYCE WAY Echo, OR 97826 |
| Contact | Charles Mack |
| Correspondent | Charles 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 | 2012-05-18 |
| Decision Date | 2012-07-16 |
| Summary: | summary |