Clearance Summary
PLASTIC SHOWER GUARD received FDA 510(k) clearance under submission number K791646, sponsored by B & F 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 1979-10-01.
- Submission: K791646
- Applicant / Sponsor: B & F Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6185
- Decision date: 1979-10-01
Classification & Regulation
This clearance is catalogued under FDA product code KIA and 21 CFR 880.6185, within the General Hospital review panel as a Class I device.