Clearance Summary
SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL received FDA 510(k) clearance under submission number K102403, sponsored by Sam Medical Products. 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 2011-03-03.
- Submission: K102403
- Applicant / Sponsor: Sam Medical Products
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4020
- Decision date: 2011-03-03
Classification & Regulation
This clearance is catalogued under FDA product code NAD and 21 CFR 878.4020, within the General, Plastic Surgery review panel as a Class I device.