Clearance Summary
ELECTROCAUTERY SYSTEM MODEL 1980 received FDA 510(k) clearance under submission number K933079, sponsored by Pmt Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1994-02-22.
- Submission: K933079
- Applicant / Sponsor: Pmt Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4115
- Decision date: 1994-02-22
Classification & Regulation
This clearance is catalogued under FDA product code HQP and 21 CFR 886.4115, within the Ophthalmic review panel as a Class II device.