Clearance Summary
SPEMBLY MEDICAL 242 CRYOUNIT/SERIES 242 CRYOPROBES received FDA 510(k) clearance under submission number K903303, sponsored by Spembly Medical , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1990-10-11.
- Submission: K903303
- Applicant / Sponsor: Spembly Medical , Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4170
- Decision date: 1990-10-11
Classification & Regulation
This clearance is catalogued under FDA product code HPS and 21 CFR 886.4170, within the Ophthalmic review panel as a Class II device.