510(k) K925017— IV PREP KIT (NON-STERILE)

Substantially Equivalent

Customed, Inc.

Clearance details

Applicant: Customed, Inc.
Product code: Code LRS
Advisory panel: General Hospital
Date received: 1992-09-24
Decision date: 1993-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fajardo, PR, US

Adverse events under product code LRS

product code LRS

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.