NEEDLE, DIALYSIS— 510(k) K902564
Substantially EquivalentGainor Medical Europe, Ltd.
FDA 510(k) clearance K902564 for NEEDLE, DIALYSIS, Substantially Equivalent on 1991-03-01. Applicant: Gainor Medical Europe, Ltd.. Device class: 2.
Clearance details
- Applicant
- Gainor Medical Europe, Ltd.
- Product code
- Code FIE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mcdonough, GA, US
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More clearances from Gainor Medical Europe, Ltd.
view allAdverse events under product code FIE
product code FIE- Death
- 2
- Total
- 2
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.