Clearance Summary
PROTECT-O-SEAL received FDA 510(k) clearance under submission number K813014, sponsored by Tri-Med, Inc.. 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 1981-11-10.
- Submission: K813014
- Applicant / Sponsor: Tri-Med, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 1981-11-10
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.