The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Sterile Water Usp And Medline Sterile 0.9% Normal Saline Usp.
| Device ID | K173276 |
| 510k Number | K173276 |
| Device Name: | Medline Sterile Water USP And Medline Sterile 0.9% Normal Saline USP |
| Classification | Dressing, Wound, Drug |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Claire Pigman |
| Correspondent | Claire Pigman Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-12 |
| Decision Date | 2018-07-02 |