Clearance Summary
BALANCED CAST SOLE received FDA 510(k) clearance under submission number K760578, sponsored by Parke-Davis Co.. 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 1976-09-27.
- Submission: K760578
- Applicant / Sponsor: Parke-Davis Co.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3025
- Decision date: 1976-09-27
Classification & Regulation
This clearance is catalogued under FDA product code IPG and 21 CFR 890.3025, within the Physical Medicine review panel as a Class I device.