The following data is part of a premarket notification filed by Changzhou City Zhiye Medical Devices Institute Co. with the FDA for Disposable Circular Stapler.
| Device ID | K131303 |
| 510k Number | K131303 |
| Device Name: | DISPOSABLE CIRCULAR STAPLER |
| Classification | Staple, Implantable |
| Applicant | CHANGZHOU CITY ZHIYE MEDICAL DEVICES INSTITUTE CO. 12226 WASHINGTON LANE Parker, AZ 85344 |
| Contact | Charlie Mack |
| Correspondent | Charlie Mack CHANGZHOU CITY ZHIYE MEDICAL DEVICES INSTITUTE CO. 12226 WASHINGTON LANE Parker, AZ 85344 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-07 |
| Decision Date | 2013-06-11 |
| Summary: | summary |