Clearance Summary
K-KLOSURE 2 INCH LENGTH/4 INCH LENGTH/8 INCH LENGTH/12 INCH LENGTH received FDA 510(k) clearance under submission number K970441, 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 1997-05-09.
- Submission: K970441
- Applicant / Sponsor: Medi-Flex Hospital Products, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5240
- Decision date: 1997-05-09
Classification & Regulation
This clearance is catalogued under FDA product code FPX and 21 CFR 880.5240, within the General Hospital review panel as a Class I device.