COLDCIDE-2— 510(k) K950553

Substantially Equivalent

Metrex Research Corp.

FDA 510(k) clearance K950553 for COLDCIDE-2, Substantially Equivalent on 1995-03-22. Applicant: Metrex Research Corp.. Device class: 1.

Clearance details

Applicant
Metrex Research Corp.
Product code
Code LRJ
Device class
Class 1
Regulation
21 CFR 880.6890
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Parker, CO, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LRJ

product code LRJ
Injury
958
Total
958

Source: openFDA MAUDE database, through . 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.