Clearance Summary
KAPTON PEEL POUCH received FDA 510(k) clearance under submission number K933228, sponsored by American Fluoroseal Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1994-03-30.
- Submission: K933228
- Applicant / Sponsor: American Fluoroseal Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2240
- Decision date: 1994-03-30
Classification & Regulation
This clearance is catalogued under FDA product code KJA and 21 CFR 864.2240, within the Hematology review panel as a Class I device.