XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and— 510(k) K142646
Substantially EquivalentGenadyne Biotechnologies, Inc.
FDA 510(k) clearance K142646 for XLR8 White Foam Dressing Kit and XLR8 White Foam Small Dressing Kit and, Substantially Equivalent on 2015-04-30. Applicant: Genadyne Biotechnologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Genadyne Biotechnologies, Inc.
- Product code
- Product code OMP
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hicksville, NY, US
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More clearances from Genadyne Biotechnologies, Inc.
view allAdverse events under product code OMP
product code OMP- Death
- 31
- Injury
- 1,707
- Malfunction
- 4,047
- Other
- 1
- Total
- 5,786
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.