The following data is part of a premarket notification filed by Touchstone International Medical Science Co., Ltd. with the FDA for Ls Series Linear Stapler And Reloads, Clc Series Curved Linear Cutter And Reloads, Lc Series Linear Cutter And Reloads.
| Device ID | K141367 |
| 510k Number | K141367 |
| Device Name: | LS SERIES LINEAR STAPLER AND RELOADS, CLC SERIES CURVED LINEAR CUTTER AND RELOADS, LC SERIES LINEAR CUTTER AND RELOADS |
| 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 | 2014-05-23 |
| Decision Date | 2014-07-25 |
| Summary: | summary |