510(k) K011120
K011120 is an FDA 510(k) premarket notification submitted by Nipro Diabetes Systems, Inc. for the device "GLUCOPRO INFUSION SET, MODEL GPISXXXXXXXX SERIES". The FDA issued a decision of Substantially Equivalent on May 8, 2001. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Nipro Diabetes Systems, Inc. has 4 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 8, 2001
- Date Received
- Apr 12, 2001
- 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)