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 | K970803 |
| 510k Number | K970803 |
| Device Name: | ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. P.O. BOX 9 Little Elm, TX 75068 -0009 |
| Contact | Terance Grisso |
| Correspondent | Terance Grisso RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. P.O. BOX 9 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 | 1997-03-04 |
| Decision Date | 1997-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613703110923 | K970803 | 000 |
| 00613703105226 | K970803 | 000 |
| 00613703105325 | K970803 | 000 |
| 00613703105424 | K970803 | 000 |
| 00613703105523 | K970803 | 000 |
| 00613703105622 | K970803 | 000 |
| 00613703105721 | K970803 | 000 |
| 00613703105820 | K970803 | 000 |
| 00613703105929 | K970803 | 000 |
| 00613703106322 | K970803 | 000 |
| 00613703110121 | K970803 | 000 |
| 00613703110220 | K970803 | 000 |
| 00613703110329 | K970803 | 000 |
| 00613703110428 | K970803 | 000 |
| 00613703110527 | K970803 | 000 |
| 00613703110626 | K970803 | 000 |
| 00613703110725 | K970803 | 000 |
| 00613703110824 | K970803 | 000 |
| 00613703105127 | K970803 | 000 |