510(k) K032848
K032848 is an FDA 510(k) premarket notification submitted by Medsolve Technologies, LLC for the device "MEDSAFE SYSTEM INSERTER". The FDA issued a decision of Substantially Equivalent on April 12, 2004. 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
- April 12, 2004
- Date Received
- September 12, 2003
- 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