The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for 0.9% Sodium Chloride Injection, Usp, Pre-filled Cop Syringe.
| Device ID | K191378 |
| 510k Number | K191378 |
| Device Name: | 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe |
| Classification | Saline, Vascular Access Flush |
| Applicant | Medline Industries, Inc. Three Lake Drive Northfield, IL 60093 |
| Contact | Stephanie Augsburg |
| Correspondent | Stephanie Augsburg Medline Industries, Inc. Three Lake Drive Northfield, IL 60093 |
| Product Code | NGT |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-23 |
| Decision Date | 2019-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20363807011179 | K191378 | 000 |