Clearance Summary
FIRST AID KIT, EYE DRESSING NSN6545-00-853-6309 received FDA 510(k) clearance under submission number K883822, sponsored by Consolidated Industries of Greater Syracuse, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1988-11-22.
- Submission: K883822
- Applicant / Sponsor: Consolidated Industries of Greater Syracuse, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4440
- Decision date: 1988-11-22
Classification & Regulation
This clearance is catalogued under FDA product code HMP and 21 CFR 878.4440, within the General, Plastic Surgery review panel as a Class I device.