The following data is part of a premarket notification filed by Retrax Safety Systems, Inc. with the FDA for Retrax Retracting Needle Syringe, Size 3cc.
| Device ID | K001017 |
| 510k Number | K001017 |
| Device Name: | RETRAX RETRACTING NEEDLE SYRINGE, SIZE 3CC |
| Classification | Syringe, Antistick |
| Applicant | RETRAX SAFETY SYSTEMS, INC. 1401 BRICKELL AVE SUITE 340 Miami, FL 33131 |
| Contact | David Garvin |
| Correspondent | David Garvin RETRAX SAFETY SYSTEMS, INC. 1401 BRICKELL AVE SUITE 340 Miami, FL 33131 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-29 |
| Decision Date | 2000-06-02 |