Clearance Summary
PMT NEW BEGINNINGS GELSHAPES & AMEND received FDA 510(k) clearance under submission number K972597, sponsored by Pmt Corp.. 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 1997-10-01.
- Submission: K972597
- Applicant / Sponsor: Pmt Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4025
- Decision date: 1997-10-01
Classification & Regulation
This clearance is catalogued under FDA product code MDA and 21 CFR 878.4025, within the General, Plastic Surgery review panel as a Class I device.