NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY— 510(k) K130995
Substantially EquivalentNuance Medical, LLC
FDA 510(k) clearance K130995 for NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY, Substantially Equivalent on 2013-06-14. Applicant: Nuance Medical, LLC.
Clearance details
- Applicant
- Nuance Medical, LLC
- Product code
- Code GEH
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Carlsbad, CA, US
Adverse events under product code GEH
product code GEH- Death
- 25
- Injury
- 351
- Malfunction
- 901
- Total
- 1,277
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.