510(k) K082837 ยท NGT Saline, Vascular Access Flush
STERILE FIELD SALINE PRE-FILLED SYRINGE(S)
| Applicant | Excelsior Medical Corp., Neptune NJ, US |
| Decision | Substantially Equivalent, Dec 18, 2008 |
| Received | Sep 26, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082837
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 4, 2022 | MEDLINE INDUSTRIES, LP - Northfield Excelsior Medical 10mL Sterile Field Saline Flush ZR, 0.9% Sodium Chloride Injection, USP, REF EMZ10091280, Sterile, IV Flush Only, Contents of Package may be dropped on a Sterile Field, 1 syringe/po Terminated |
NGT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.