510(k) K001017
K001017 is an FDA 510(k) premarket notification submitted by Retrax Safety Systems, Inc. for the device "RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC". The FDA issued a decision of Substantially Equivalent on Jun 2, 2000. The device falls under product code MEG (Syringe, Antistick), a Class II device regulated under 21 CFR 880.5860.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 2, 2000
- Date Received
- Mar 29, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Syringe, Antistick
- Device Class
- Class II
- Regulation Number
- 880.5860
- Review Panel
- HO
- Submission Type
- 510(k)