The following data is part of a premarket notification filed by Retractable Technologies, Inc. with the FDA for Anti-stick Syringe With Integral Hypodermic Needle/vanishpoint Syringe.
| Device ID | K973301 |
| 510k Number | K973301 |
| Device Name: | ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. Little Elm, TX 75068 -0009 |
| Contact | Grisso |
| Correspondent | Grisso RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. Little Elm, TX 75068 -0009 |
| Product Code | MEG |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-02 |
| Decision Date | 1997-11-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613703153920 | K973301 | 000 |
| 00613703102324 | K973301 | 000 |
| 00613703102522 | K973301 | 000 |
| 00613703102720 | K973301 | 000 |
| 00613703102829 | K973301 | 000 |
| 00613703102928 | K973301 | 000 |
| 00613703152220 | K973301 | 000 |
| 00613703152725 | K973301 | 000 |
| 00613703152923 | K973301 | 000 |
| 00613703153722 | K973301 | 000 |
| 00613703102126 | K973301 | 000 |