Clearance Summary
BREAST CARE KIT received FDA 510(k) clearance under submission number K760911, sponsored by American Hospital Supply Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1976-11-11.
- Submission: K760911
- Applicant / Sponsor: American Hospital Supply Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5150
- Decision date: 1976-11-11
Classification & Regulation
This clearance is catalogued under FDA product code HGY and 21 CFR 884.5150, within the Obstetrics/Gynecology review panel as a Class I device.