Clearance Summary
PROCESS INDICATOR TAPE FOR STEAM STERILIZATION received FDA 510(k) clearance under submission number K140940, sponsored by Canadian Technical Tape, Ltd.. 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 2014-10-27.
- Submission: K140940
- Applicant / Sponsor: Canadian Technical Tape, Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2014-10-27
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.