Clearance Summary
FITPACK received FDA 510(k) clearance under submission number K060037, sponsored by Asp Plastics Pty , Ltd.. 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 2006-07-25.
- Submission: K060037
- Applicant / Sponsor: Asp Plastics Pty , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5570
- Decision date: 2006-07-25
Classification & Regulation
This clearance is catalogued under FDA product code MMK and 21 CFR 880.5570, within the General Hospital review panel as a Class II device.