Clearance Summary
AGILANCE-GOLDEN SPOONS received FDA 510(k) clearance under submission number K936178, sponsored by Oismuller & Partner Keg. 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 1995-01-18.
- Submission: K936178
- Applicant / Sponsor: Oismuller & Partner Keg
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5660
- Decision date: 1995-01-18
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.