Clearance Summary
SKIN PRESSURE PROTECTORS received FDA 510(k) clearance under submission number K761268, sponsored by Mark One Healthcare Products. 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 1977-02-16.
- Submission: K761268
- Applicant / Sponsor: Mark One Healthcare Products
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6450
- Decision date: 1977-02-16
Classification & Regulation
This clearance is catalogued under FDA product code FMP and 21 CFR 880.6450, within the General Hospital review panel as a Class I device.