Clearance Summary
UNICARE BREAST SHELLS received FDA 510(k) clearance under submission number K861608, sponsored by Unicare Medical 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 1986-07-15.
- Submission: K861608
- Applicant / Sponsor: Unicare Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5630
- Decision date: 1986-07-15
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.