Clearance Summary
ADAPTAIN, ADAPTAIN FASTWRAP, ENVELOCK, BIOWAI received FDA 510(k) clearance under submission number K132198, sponsored by Ceremed , Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2013-09-12.
- Submission: K132198
- Applicant / Sponsor: Ceremed , Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class II
- Regulation citation: 21 CFR 874.3620
- Decision date: 2013-09-12
Classification & Regulation
This clearance is catalogued under FDA product code KHJ and 21 CFR 874.3620, within the Ear, Nose, Throat review panel as a Class II device.