Clearance Summary
PARALLELING GUIDES received FDA 510(k) clearance under submission number K914715, sponsored by Implant Corp. of America. 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 1994-02-16.
- Submission: K914715
- Applicant / Sponsor: Implant Corp. of America
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4800
- Decision date: 1994-02-16
Classification & Regulation
This clearance is catalogued under FDA product code FZX and 21 CFR 878.4800, within the General, Plastic Surgery review panel as a Class I device.