Clearance Summary
PHARMACY ADDITIVE SYRINGE SET received FDA 510(k) clearance under submission number K800213, sponsored by Cutter Laboratories, 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 1980-02-26.
- Submission: K800213
- Applicant / Sponsor: Cutter Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6430
- Decision date: 1980-02-26
Classification & Regulation
This clearance is catalogued under FDA product code KYW and 21 CFR 880.6430, within the General Hospital review panel as a Class I device.