Clearance Summary
TAPE MEASURE received FDA 510(k) clearance under submission number K760521, sponsored by Mcgaw Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 1976-11-12.
- Submission: K760521
- Applicant / Sponsor: Mcgaw Laboratories
- Clearance pathway: Traditional
- Review panel: Orthopedic
- Device class: Class I
- Regulation citation: 21 CFR 888.4150
- Decision date: 1976-11-12
Classification & Regulation
This clearance is catalogued under FDA product code KTZ and 21 CFR 888.4150, within the Orthopedic review panel as a Class I device.