510(k) K012845
K012845 is an FDA 510(k) premarket notification submitted by Sterling Medivations, Inc. for the device "SIMPLICITY SOFT QD MICRO INFUSION SET". The FDA issued a decision of Substantially Equivalent on Sep 14, 2001. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Sterling Medivations, Inc. has 26 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 14, 2001
- Date Received
- Aug 23, 2001
- Clearance Type
- Abbreviated
- 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)