Clearance Summary
COTTON SWABS received FDA 510(k) clearance under submission number K820962, sponsored by Dafoe & Dafoe, 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 1982-04-20.
- Submission: K820962
- Applicant / Sponsor: Dafoe & Dafoe, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6025
- Decision date: 1982-04-20
Classification & Regulation
This clearance is catalogued under FDA product code KXF and 21 CFR 880.6025, within the General Hospital review panel as a Class I device.