Clearance Summary
HILARIS-NORI CERVIX APPLICATOR received FDA 510(k) clearance under submission number K891377, sponsored by Mick Radio-Nuclear Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1989-04-14.
- Submission: K891377
- Applicant / Sponsor: Mick Radio-Nuclear Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.5650
- Decision date: 1989-04-14
Classification & Regulation
This clearance is catalogued under FDA product code IWJ and 21 CFR 892.5650, within the Radiology review panel as a Class I device.