The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Anti-fog Solution.
| Device ID | K152948 |
| 510k Number | K152948 |
| Device Name: | Medline Anti-Fog Solution |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| 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 | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-06 |
| Decision Date | 2016-02-04 |