The following data is part of a premarket notification filed by Covidien with the FDA for Reprocessed Kendall Scd Express Compression Sleeves, Reprocessed Kendall Scd Comfort Compression Sleeves.
| Device ID | K163620 |
| 510k Number | K163620 |
| Device Name: | Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves |
| Classification | Sleeve, Limb, Compressible |
| Applicant | Covidien 15 Hampshire Stree Mansfield, MA 02048 |
| Contact | Nicole Genco |
| Correspondent | Nicole Genco Covidien 15 Hampshire Stree Mansfield, MA 02048 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-22 |
| Decision Date | 2017-01-19 |
| Summary: | summary |