Clearance Summary
ACTI-FLEX LOW, MEDIUM, RESCARE I, RESCARE II. received FDA 510(k) clearance under submission number K952470, sponsored by R-Group Intl.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1995-11-28.
- Submission: K952470
- Applicant / Sponsor: R-Group Intl.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1995-11-28
Classification & Regulation
This clearance is catalogued under FDA product code GCD and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.