Clearance Summary
PIASMA SAFE received FDA 510(k) clearance under submission number K792185, sponsored by Cry-O-Safe, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1979-12-28.
- Submission: K792185
- Applicant / Sponsor: Cry-O-Safe, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.9100
- Decision date: 1979-12-28
Classification & Regulation
This clearance is catalogued under FDA product code KSR and 21 CFR 864.9100, within the Hematology review panel as a Class II device.