Clearance Summary
PRE-PADDED PLASTER/PARIS BAND/SPLINTS received FDA 510(k) clearance under submission number K800752, sponsored by Ortho-Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1980-04-21.
- Submission: K800752
- Applicant / Sponsor: Ortho-Care, Inc.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3025
- Decision date: 1980-04-21
Classification & Regulation
This clearance is catalogued under FDA product code ITG and 21 CFR 890.3025, within the Physical Medicine review panel as a Class I device.