The following data is part of a premarket notification filed by Surgical Devices, A Global Business Unit Covidien with the FDA for Covidien Sports Surgery As Meniscal Repair Device.
| Device ID | K082535 |
| 510k Number | K082535 |
| Device Name: | COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN 60 Middletown Ave North Haven, CT 06473 |
| Contact | Tim M Lohnes |
| Correspondent | Tim M Lohnes SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN 60 Middletown Ave North Haven, CT 06473 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-02 |
| Decision Date | 2008-12-01 |
| Summary: | summary |