Clearance Summary
EXAPHASE, SINGLE PHASE IMPRESSION MATERIAL received FDA 510(k) clearance under submission number K902531, sponsored by G-C Intl. Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1990-07-13.
- Submission: K902531
- Applicant / Sponsor: G-C Intl. Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1900
- Decision date: 1990-07-13
Classification & Regulation
This clearance is catalogued under FDA product code EGW and 21 CFR 892.1900, within the Radiology review panel as a Class II device.