Clearance Summary
KACEY DISPOSABLE INFANT HEEL WARMER received FDA 510(k) clearance under submission number K934673, sponsored by K & C Medical, Inc.. 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 1994-02-02.
- Submission: K934673
- Applicant / Sponsor: K & C Medical, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.5710
- Decision date: 1994-02-02
Classification & Regulation
This clearance is catalogued under FDA product code IMD and 21 CFR 890.5710, within the Physical Medicine review panel as a Class I device.