510(k) K124026
K124026 is an FDA 510(k) premarket notification submitted by Scandinavian Health Limited for the device "LOBSTER AUTO-INJECTOR". The FDA issued a decision of Substantially Equivalent on September 13, 2013. The device falls under product code KZH (Introducer, Syringe Needle), a Class II device regulated under 21 CFR 880.6920. Scandinavian Health Limited has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 2013
- Date Received
- December 28, 2012
- 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