Clearance Summary
COMPOUND BENZOIN TINCTURE USP FREPP received FDA 510(k) clearance under submission number K920399, sponsored by Medi-Flex Hospital 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 1994-01-25.
- Submission: K920399
- Applicant / Sponsor: Medi-Flex Hospital Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5090
- Decision date: 1994-01-25
Classification & Regulation
This clearance is catalogued under FDA product code KMF and 21 CFR 880.5090, within the General Hospital review panel as a Class I device.