SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM— 510(k) K112936

Substantially Equivalent

Rexam Consummer Plastics Inc.D/B/A Rexam Pharma

FDA 510(k) clearance K112936 for SAFE'SOUND LUER LOCK PASSIVE DEVLIVERY SYSTEM, Substantially Equivalent on 2012-01-20. Applicant: Rexam Consummer Plastics Inc.D/B/A Rexam Pharma.

Clearance details

Applicant: Rexam Consummer Plastics Inc.D/B/A Rexam Pharma
Product code: Code MEG
Advisory panel: General Hospital
Date received: 2011-10-03
Decision date: 2012-01-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Buffalo Grove, IL, US

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Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

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.