Clearance Summary
NOVIGUARD QUICK DRY received FDA 510(k) clearance under submission number K961044, sponsored by Dr. Novis Smith & Co., 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 1997-07-03.
- Submission: K961044
- Applicant / Sponsor: Dr. Novis Smith & Co., Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6890
- Decision date: 1997-07-03
Classification & Regulation
This clearance is catalogued under FDA product code LRJ and 21 CFR 880.6890, within the General Hospital review panel as a Class I device.