The following data is part of a premarket notification filed by Covidien Llc with the FDA for Accumesh Deployment System.
| Device ID | K121139 |
| 510k Number | K121139 |
| Device Name: | ACCUMESH DEPLOYMENT SYSTEM |
| Classification | Mesh, Surgical, Deployer |
| Applicant | Covidien LLC 15 CROSBY DR Bedford, MA 01730 |
| Contact | James Mcmahon |
| Correspondent | James Mcmahon Covidien LLC 15 CROSBY DR Bedford, MA 01730 |
| Product Code | ORQ |
| CFR Regulation Number | 878.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-16 |
| Decision Date | 2012-05-02 |
| Summary: | summary |