Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator— 510(k) K162721
Substantially EquivalentAlliqua Biomedical, Inc.
FDA 510(k) clearance K162721 for Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator, Substantially Equivalent on 2016-12-22. Applicant: Alliqua Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Alliqua Biomedical, Inc.
- Product code
- Code NRB
- Device class
- Class 2
- Regulation
- 21 CFR 878.4410
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Eden Prairie, MN, US
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More clearances from Alliqua Biomedical, Inc.
view allAdverse events under product code NRB
product code NRB- Other
- 1
- Total
- 1
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.