Clearance Summary
BREAST SHELL received FDA 510(k) clearance under submission number K944177, sponsored by O'Donnell, Byrne & Williams. 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 1994-10-05.
- Submission: K944177
- Applicant / Sponsor: O'Donnell, Byrne & Williams
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5630
- Decision date: 1994-10-05
Classification & Regulation
This clearance is catalogued under FDA product code HFS and 21 CFR 880.5630, within the General Hospital review panel as a Class I device.