Clearance Summary
CRYOLYZER ALPHA (CRYOSURG.EQUIP.) received FDA 510(k) clearance under submission number K760686, sponsored by Cryo-Labs, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1976-11-01.
- Submission: K760686
- Applicant / Sponsor: Cryo-Labs, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4350
- Decision date: 1976-11-01
Classification & Regulation
This clearance is catalogued under FDA product code GEH and 21 CFR 878.4350, within the General, Plastic Surgery review panel as a Class II device.