Clearance Summary
YESONA PLASTER OF PARIS BANDAGE received FDA 510(k) clearance under submission number K831492, sponsored by Watson Phillips Y Cia. Sucs., S.A. DE C.V.. 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 1983-06-30.
- Submission: K831492
- Applicant / Sponsor: Watson Phillips Y Cia. Sucs., S.A. DE C.V.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3025
- Decision date: 1983-06-30
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.