Clearance Summary
KUSKE BREAST APPLICATOR SET, MODEL 189.006 received FDA 510(k) clearance under submission number K022635, sponsored by Nucletron Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2002-09-06.
- Submission: K022635
- Applicant / Sponsor: Nucletron Corporation
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 2002-09-06
Classification & Regulation
This clearance is catalogued under FDA product code JAQ and 21 CFR 892.5700, within the Radiology review panel as a Class II device.