The following data is part of a premarket notification filed by Medline, Industries, Inc. with the FDA for Curad Compression Hosiery.
Device ID | K112769 |
510k Number | K112769 |
Device Name: | CURAD COMPRESSION HOSIERY |
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 | 2011-09-23 |
Decision Date | 2012-03-01 |