The following data is part of a premarket notification filed by Retractable Technologies, Inc. with the FDA for Patient Safe Syringe.
| Device ID | K072654 |
| 510k Number | K072654 |
| Device Name: | PATIENT SAFE SYRINGE |
| Classification | Syringe, Piston |
| Applicant | RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. Little Elm, TX 75068 -0009 |
| Contact | Rhonda Wells |
| Correspondent | Rhonda Wells RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. Little Elm, TX 75068 -0009 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-20 |
| Decision Date | 2007-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613703560025 | K072654 | 000 |
| 00613703530028 | K072654 | 000 |
| 00613703520029 | K072654 | 000 |
| 00613703510020 | K072654 | 000 |
| 00613703505026 | K072654 | 000 |
| 00613703503022 | K072654 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PATIENT SAFE SYRINGE 85283764 4136822 Live/Registered |
Retractable Technologies, Inc. 2011-04-01 |
![]() PATIENT SAFE SYRINGE 77170321 not registered Dead/Abandoned |
Retractable Technologies, Inc. 2007-05-01 |