510(k) K192057
K-Pack II Needle - 27G x 1/2 Extra Thin Wall, K-Pack II Needle - 27G x 1/2 Ultra Thin Wall, K-Pack II Needle - 30G x 1/2 Extra Thin Wall, K-Pack II Needle - 30G x 1/2 Ultra Thin Wall by
Terumo Europe N.V.
— Product Code FMI
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 11, 2019
- Date Received
- August 1, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Needle, Hypodermic, Single Lumen
- Device Class
- Class II
- Regulation Number
- 880.5570
- Review Panel
- HO
- Submission Type