The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Waste Station.
Device ID | K160660 |
510k Number | K160660 |
Device Name: | Medline Waste Station |
Classification | Catheter, Intravascular, Diagnostic |
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 | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-08 |
Decision Date | 2017-01-19 |