The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Natural Lubricating Liquid.
Device ID | K143322 |
510k Number | K143322 |
Device Name: | Medline Natural Lubricating Liquid |
Classification | Lubricant, Personal |
Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundlelein, IL 60060 |
Contact | Jennifer Mason |
Correspondent | Jennifer Mason MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundlelein, IL 60060 |
Product Code | NUC |
CFR Regulation Number | 884.5300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-11-19 |
Decision Date | 2015-07-20 |