The following data is part of a premarket notification filed by Covidien with the FDA for Kendall Scd 700 Sequential Compression Controller.
Device ID | K132360 |
510k Number | K132360 |
Device Name: | KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER |
Classification | Sleeve, Limb, Compressible |
Applicant | COVIDIEN 15 HAMPSHIRE STREET Mansfield, MA 02048 |
Contact | Ashley Goncalo |
Correspondent | Ashley Goncalo COVIDIEN 15 HAMPSHIRE STREET 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 | 2013-07-30 |
Decision Date | 2013-08-27 |