Clearance Summary
SPAND-GEL GRANULATED GEL received FDA 510(k) clearance under submission number K864124, sponsored by Medi-Tech Intl. Corp.. 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 1986-11-26.
- Submission: K864124
- Applicant / Sponsor: Medi-Tech Intl. Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.5090
- Decision date: 1986-11-26
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.