510(k) K926448
K926448 is an FDA 510(k) premarket notification submitted by Gainor Medical Europe, Ltd. for the device "I.V. ADMINISTRATION SET". The FDA issued a decision of Substantially Equivalent on May 2, 1994. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Gainor Medical Europe, Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 1994
- Date Received
- December 23, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type