Clearance Summary
SHIRT, MITTEN CUFF INFANT received FDA 510(k) clearance under submission number K760360, sponsored by Precept, 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 1976-10-20.
- Submission: K760360
- Applicant / Sponsor: Precept, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6265
- Decision date: 1976-10-20
Classification & Regulation
This clearance is catalogued under FDA product code FME and 21 CFR 880.6265, within the General Hospital review panel as a Class I device.