The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for 0.9% Sodium Chloride Injection, Usp.
| Device ID | K173348 |
| 510k Number | K173348 |
| Device Name: | 0.9% Sodium Chloride Injection, USP |
| Classification | Saline, Vascular Access Flush |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen Medline Industries, Inc. Three Lakes 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 | 2017-10-25 |
| Decision Date | 2018-06-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30888277675814 | K173348 | 000 |
| 20888277676098 | K173348 | 000 |
| 10888277664333 | K173348 | 000 |
| 20888277676111 | K173348 | 000 |