Clearance Summary
PMT(R) SILICONE GEL SHEETING MODEL 3505-1 received FDA 510(k) clearance under submission number K930409, 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 1993-09-01.
- Submission: K930409
- Applicant / Sponsor: Pmt Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4025
- Decision date: 1993-09-01
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.