Clearance Summary
Steri-Cassette and Steri-Cage Sterilization Packaging System received FDA 510(k) clearance under submission number K162063, sponsored by Sybron Dental Specialties. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2017-04-21.
- Submission: K162063
- Applicant / Sponsor: Sybron Dental Specialties
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6850
- Decision date: 2017-04-21
Classification & Regulation
This clearance is catalogued under FDA product code KCT and 21 CFR 880.6850, within the General Hospital review panel as a Class II device.