Clearance Summary
C3 Wave System received FDA 510(k) clearance under submission number K170934, sponsored by Medical Components, Inc (Dba Medcomp_. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2017-12-06.
- Submission: K170934
- Applicant / Sponsor: Medical Components, Inc (Dba Medcomp_
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 2017-12-06
Classification & Regulation
This clearance is catalogued under FDA product code LJS and 21 CFR 880.5970, within the General Hospital review panel as a Class II device.