Clearance Summary
BIRDIE BRACKET received FDA 510(k) clearance under submission number K872028, sponsored by William W. Wilkerson & Gregory A. Knutson. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1987-07-31.
- Submission: K872028
- Applicant / Sponsor: William W. Wilkerson & Gregory A. Knutson
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5660
- Decision date: 1987-07-31
Classification & Regulation
This clearance is catalogued under FDA product code ISA and 21 CFR 890.5660, within the Physical Medicine review panel as a Class I device.