The following data is part of a premarket notification filed by Core Essence Orthopaedics, Llc with the FDA for Ferrofibre Stainless Steel Sutures, Model 610 Series Sizes (usp) 5-0 To #5.
| Device ID | K081060 |
| 510k Number | K081060 |
| Device Name: | FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 |
| Classification | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile |
| Applicant | CORE ESSENCE ORTHOPAEDICS, LLC 301 OXFORD VALLEY RD. SUITE 905B Yardley, PA 19067 |
| Contact | Shawn T Huxel |
| Correspondent | Shawn T Huxel CORE ESSENCE ORTHOPAEDICS, LLC 301 OXFORD VALLEY RD. SUITE 905B Yardley, PA 19067 |
| Product Code | GAQ |
| CFR Regulation Number | 878.4495 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-14 |
| Decision Date | 2008-12-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859210006032 | K081060 | 000 |
| 00859210006018 | K081060 | 000 |