Clearance Summary
I.V. SKY-HOOK received FDA 510(k) clearance under submission number K912010, sponsored by Dina - Industria, Comercio E Exportacao , Ltd.. 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 1991-08-19.
- Submission: K912010
- Applicant / Sponsor: Dina - Industria, Comercio E Exportacao , Ltd.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6990
- Decision date: 1991-08-19
Classification & Regulation
This clearance is catalogued under FDA product code FOX and 21 CFR 880.6990, within the General Hospital review panel as a Class I device.