The following data is part of a premarket notification filed by Retractable Technologies, Inc. with the FDA for Vanishpoint Syringe.
| Device ID | K980069 |
| 510k Number | K980069 |
| Device Name: | VANISHPOINT SYRINGE |
| Classification | Syringe, Antistick |
| Applicant | RETRACTABLE TECHNOLOGIES, INC. 511 LOBO LN. Little Elm, TX 75068 -0009 |
| Contact | Terance Grisso |
| Correspondent | Terance 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 | 1998-01-08 |
| Decision Date | 1998-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613703901392 | K980069 | 000 |
| 00613703104328 | K980069 | 000 |
| 00613703101723 | K980069 | 000 |
| 00613703101624 | K980069 | 000 |
| 00613703101525 | K980069 | 000 |
| 00613703101341 | K980069 | 000 |
| 00613703101327 | K980069 | 000 |