The following data is part of a premarket notification filed by Touchstone International Medical Science Co., Ltd. with the FDA for Csc Series Intraluminal Stapler For Single Use.
| Device ID | K141097 |
| 510k Number | K141097 |
| Device Name: | CSC SERIES INTRALUMINAL STAPLER FOR SINGLE USE |
| Classification | Staple, Implantable |
| Applicant | TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD. 21A SCIENCE PLAZA, INTRENATIONAL SCIENCE PARK NO.1355 JINJIHU AVENUE Suzhou, Jiangsu, CN 215021 |
| Contact | Jo Qiao |
| Correspondent | Jo Qiao TOUCHSTONE INTERNATIONAL MEDICAL SCIENCE CO., LTD. 21A SCIENCE PLAZA, INTRENATIONAL SCIENCE PARK NO.1355 JINJIHU AVENUE Suzhou, Jiangsu, CN 215021 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-28 |
| Decision Date | 2014-09-26 |
| Summary: | summary |