The following data is part of a premarket notification filed by Retractable Technologies, Inc. with the FDA for Vanishpoint Blood Collection Set.
| Device ID | K122355 |
| 510k Number | K122355 |
| Device Name: | VANISHPOINT BLOOD COLLECTION SET |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | RETRACTABLE TECHNOLOGIES, INC. 511 Lobo Ln Little Elm, TX 75068 |
| Contact | Rhonda Wells |
| Correspondent | Rhonda Wells RETRACTABLE TECHNOLOGIES, INC. 511 Lobo Ln Little Elm, TX 75068 |
| Product Code | JKA |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-03 |
| Decision Date | 2013-08-23 |
| Summary: | summary |