510(k) K780883
K780883 is an FDA 510(k) premarket notification submitted by Harco Products for the device "E-Z-JECTOR". The FDA issued a decision of Substantially Equivalent on August 10, 1978. The device falls under product code KZA (Device, Vein Location, Liquid Crystal), a Class I device regulated under 21 CFR 880.6970. Harco Products has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 1978
- Date Received
- May 30, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Vein Location, Liquid Crystal
- Device Class
- Class I
- Regulation Number
- 880.6970
- Review Panel
- HO
- Submission Type