Clearance Summary
PHYSICIANS CHOICE SILICONE EAR PUTTY received FDA 510(k) clearance under submission number K823921, sponsored by Santa Barbara Medco, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 1983-03-28.
- Submission: K823921
- Applicant / Sponsor: Santa Barbara Medco, Inc.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.3300
- Decision date: 1983-03-28
Classification & Regulation
This clearance is catalogued under FDA product code LDG and 21 CFR 874.3300, within the Ear, Nose, Throat review panel as a Class I device.