The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Hemo-force Dvt Compression Sleeve.
Device ID | K170415 |
510k Number | K170415 |
Device Name: | Medline Hemo-Force DVT Compression Sleeve |
Classification | Sleeve, Limb, Compressible |
Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
Contact | Matt Clausen |
Correspondent | Matt Clausen Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
Product Code | JOW |
CFR Regulation Number | 870.5800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-02-10 |
Decision Date | 2017-09-08 |