Clearance Summary
PLAGIOCEPHALIC APPLIED PRESSURE ORTHOSIS P.A.P. ORTHOSIS received FDA 510(k) clearance under submission number K012804, sponsored by Scott E Allen CP. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2002-01-17.
- Submission: K012804
- Applicant / Sponsor: Scott E Allen CP
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5970
- Decision date: 2002-01-17
Classification & Regulation
This clearance is catalogued under FDA product code MVA and 21 CFR 882.5970, within the Neurology review panel as a Class II device.