Clearance Summary
SOLACE POST-OPERATIVE PAIN RELIEF INFUSION SYSTEM received FDA 510(k) clearance under submission number K060933, sponsored by Apex Medical Technologies, Inc.. 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 2006-05-09.
- Submission: K060933
- Applicant / Sponsor: Apex Medical Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 2006-05-09
Classification & Regulation
This clearance is catalogued under FDA product code MEB and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.