510(k) K002127
K002127 is an FDA 510(k) premarket notification submitted by Sterling Medivations, Inc. for the device "INJECTRITE-C15 AND INJECTRITE-C30". The FDA issued a decision of Substantially Equivalent on Dec 29, 2000. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Sterling Medivations, Inc. has 26 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 29, 2000
- Date Received
- Jul 14, 2000
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Syringe, Piston
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)