Clearance Summary
BREATHABLE MINI-SHIELD-PRIVATE LABEL received FDA 510(k) clearance under submission number K843602, sponsored by I.C.D. Industries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1984-10-05.
- Submission: K843602
- Applicant / Sponsor: I.C.D. Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.5435
- Decision date: 1984-10-05
Classification & Regulation
This clearance is catalogued under FDA product code HHD and 21 CFR 884.5435, within the Obstetrics/Gynecology review panel as a Class I device.