Clearance Summary
Canadian Technical Tape, LTd. LF Process Indicator Steam Sterilization Tape received FDA 510(k) clearance under submission number K161024, sponsored by Canadian Technical Tape, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2016-06-28.
- Submission: K161024
- Applicant / Sponsor: Canadian Technical Tape, Ltd.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2016-06-28
Classification & Regulation
This clearance is catalogued under FDA product code JOJ and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.