Clearance Summary
DALE VENIPUNCTURE TOURNIQUET, PRODUCT NO. 1335 received FDA 510(k) clearance under submission number K864897, sponsored by Dale Medical Products, 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 1987-01-12.
- Submission: K864897
- Applicant / Sponsor: Dale Medical Products, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.5900
- Decision date: 1987-01-12
Classification & Regulation
This clearance is catalogued under FDA product code GAX and 21 CFR 878.5900, within the General, Plastic Surgery review panel as a Class I device.