The following data is part of a premarket notification filed by Covidien with the FDA for Reprocessed Kendall Scd Express Compression Sleeves.
| Device ID | K140813 |
| 510k Number | K140813 |
| Device Name: | REPROCESSED KENDALL SCD EXPRESS COMPRESSION SLEEVES |
| Classification | Sleeve, Limb, Compressible |
| Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Contact | Daniel Campion |
| Correspondent | Daniel Campion COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-01 |
| Decision Date | 2014-07-15 |
| Summary: | summary |