Clearance Summary
PACK & PROPER PACK & PROPER, EAR-THERMOMETER PROBE CAP received FDA 510(k) clearance under submission number K042653, sponsored by Pack & Proper Co., Ltd.. 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 2004-11-26.
- Submission: K042653
- Applicant / Sponsor: Pack & Proper Co., Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2910
- Decision date: 2004-11-26
Classification & Regulation
This clearance is catalogued under FDA product code FLL and 21 CFR 880.2910, within the General Hospital review panel as a Class II device.