Clearance Summary
GO-CLEAN received FDA 510(k) clearance under submission number K922110, sponsored by Viva-Tek Assoc., Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1994-03-09.
- Submission: K922110
- Applicant / Sponsor: Viva-Tek Assoc., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5450
- Decision date: 1994-03-09
Classification & Regulation
This clearance is catalogued under FDA product code FRR and 21 CFR 880.5450, within the General Hospital review panel as a Class II device.