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 |