Clearance Summary
TECNOL SECURE-ALL PELVIC TRACTION BELT received FDA 510(k) clearance under submission number K882640, sponsored by Tecnol New Jersey Wound Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1988-07-27.
- Submission: K882640
- Applicant / Sponsor: Tecnol New Jersey Wound Care, Inc.
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.5890
- Decision date: 1988-07-27
Classification & Regulation
This clearance is catalogued under FDA product code KQZ and 21 CFR 888.5890, within the Orthopedic review panel as a Class I device.