Clearance Summary
PY30, PY60, PY80 received FDA 510(k) clearance under submission number K944928, sponsored by Huttinger Medizintechnik GmbH & CO KG. 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 1995-01-27.
- Submission: K944928
- Applicant / Sponsor: Huttinger Medizintechnik GmbH & CO KG
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4810
- Decision date: 1995-01-27
Classification & Regulation
This clearance is catalogued under FDA product code GEX and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.