The following data is part of a premarket notification filed by Teleflex Medical, Inc. with the FDA for Weck Efx Endo Fascial Closure System.
| Device ID | K132362 |
| 510k Number | K132362 |
| Device Name: | WECK EFX ENDO FASCIAL CLOSURE SYSTEM |
| Classification | Endoscopic Tissue Approximation Device |
| Applicant | Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Contact | Natalie Hichak |
| Correspondent | Natalie Hichak Teleflex Medical, Inc. 2917 WECK DR. Research Triangle Park, NC 27709 |
| Product Code | OCW |
| Subsequent Product Code | GCJ |
| Subsequent Product Code | HCF |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-30 |
| Decision Date | 2013-10-08 |
| Summary: | summary |