Clearance Summary
SPECTRA MEDICAL SAFETY SCAPEL received FDA 510(k) clearance under submission number K091462, sponsored by Spectra, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2009-12-15.
- Submission: K091462
- Applicant / Sponsor: Spectra, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 2009-12-15
Classification & Regulation
This clearance is catalogued under FDA product code GDZ and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.