Clearance Summary
INFANT SCALE DISPOSABLE LINER received FDA 510(k) clearance under submission number K790659, sponsored by Hydro-Med Products, 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 1979-04-30.
- Submission: K790659
- Applicant / Sponsor: Hydro-Med Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6060
- Decision date: 1979-04-30
Classification & Regulation
This clearance is catalogued under FDA product code KME and 21 CFR 880.6060, within the General Hospital review panel as a Class I device.