Clearance Summary
DYNASTY U1-31 (GELL/CELL) received FDA 510(k) clearance under submission number K942309, sponsored by Foley & Lardner. 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 1994-11-07.
- Submission: K942309
- Applicant / Sponsor: Foley & Lardner
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3920
- Decision date: 1994-11-07
Classification & Regulation
This clearance is catalogued under FDA product code KNN and 21 CFR 890.3920, within the Physical Medicine review panel as a Class I device.