Clearance Summary
MACLEAN-FOGG, DISP. BASE MOLD received FDA 510(k) clearance under submission number K831900, sponsored by Polymer Technology Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1983-07-28.
- Submission: K831900
- Applicant / Sponsor: Polymer Technology Corp.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.3010
- Decision date: 1983-07-28
Classification & Regulation
This clearance is catalogued under FDA product code KER and 21 CFR 864.3010, within the Pathology review panel as a Class I device.