The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Quick-clear Wand.
Device ID | K183577 |
510k Number | K183577 |
Device Name: | Medline Quick-Clear Wand |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
Contact | Dinah Rincones |
Correspondent | Dinah Rincones Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-12-21 |
Decision Date | 2019-05-04 |