The following data is part of a premarket notification filed by Retrax, Inc. with the FDA for Retrax Safety Syringe.
| Device ID | K901508 |
| 510k Number | K901508 |
| Device Name: | RETRAX SAFETY SYRINGE |
| Classification | Syringe, Piston |
| Applicant | RETRAX, INC. 444 HOLDERIETH Tomball, TX 77375 |
| Contact | Walter W Gloyer |
| Correspondent | Walter W Gloyer RETRAX, INC. 444 HOLDERIETH Tomball, TX 77375 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-30 |
| Decision Date | 1990-06-14 |