Clearance Summary
PCM 2000; ISOLAIR APR MODEL 2735 received FDA 510(k) clearance under submission number K970448, sponsored by Tecnol Medical Products, Inc.. 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 1997-04-30.
- Submission: K970448
- Applicant / Sponsor: Tecnol Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4040
- Decision date: 1997-04-30
Classification & Regulation
This clearance is catalogued under FDA product code MSH and 21 CFR 878.4040, within the General, Plastic Surgery review panel as a Class II device.