SPECTRA MEDICAL SAFETY SCAPEL— 510(k) K091462
Substantially EquivalentSpectra, Inc.
FDA 510(k) clearance K091462 for SPECTRA MEDICAL SAFETY SCAPEL, Substantially Equivalent on 2009-12-15. Applicant: Spectra, Inc..
Clearance details
- Applicant
- Spectra, Inc.
- Product code
- Code GDZ
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, MA, US
Adverse events under product code GDZ
product code GDZ- 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.