510(k) K180843
K180843 is an FDA 510(k) premarket notification submitted by Repro-Med Systems, Inc. Dba Rms Medical Products for the device "HIgH-Flo Super26 Subcutaneous Needle Sets". The FDA issued a decision of Substantially Equivalent on Apr 4, 2019. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Repro-Med Systems, Inc. Dba Rms Medical Products has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 4, 2019
- Date Received
- Apr 2, 2018
- 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
- 510(k)