Clearance Summary
CUDDLE UP PILLOW received FDA 510(k) clearance under submission number K882544, sponsored by Ohio Medical Instrument Co., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1989-01-31.
- Submission: K882544
- Applicant / Sponsor: Ohio Medical Instrument Co., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5680
- Decision date: 1989-01-31
Classification & Regulation
This clearance is catalogued under FDA product code FRP and 21 CFR 880.5680, within the General Hospital review panel as a Class I device.