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 With High Strength Suture.
| Device ID | K091016 |
| 510k Number | K091016 |
| Device Name: | COVIDIEN SPORTS SURGERY AS MENISCAL REPAIR DEVICE WITH HIGH STRENGTH SUTURE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-09 |
| Decision Date | 2009-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521154582 | K091016 | 000 |
| 10884521154575 | K091016 | 000 |
| 10884521154605 | K091016 | 000 |
| 10884521154599 | K091016 | 000 |