The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Anti-embolism Stocking.
Device ID | K141127 |
510k Number | K141127 |
Device Name: | MEDLINE ANTI-EMBOLISM STOCKING |
Classification | Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) |
Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
Contact | Matt Clausen |
Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
Product Code | DWL |
CFR Regulation Number | 880.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-05-01 |
Decision Date | 2014-08-21 |