510(k) K954729
K954729 is an FDA 510(k) premarket notification submitted by Scandinavian Health , Ltd. for the device "PEN-INJECT 2.25". The FDA issued a decision of Substantially Equivalent on Jan 29, 1996. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 29, 1996
- Date Received
- Oct 13, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Introducer, Syringe Needle
- Device Class
- Class II
- Regulation Number
- 880.6920
- Review Panel
- HO
- Submission Type
- 510(k)