The following data is part of a premarket notification filed by Retractable Technologies, Inc. with the FDA for Vanishpoint Blood Collection Set.
| Device ID | K112512 |
| 510k Number | K112512 |
| Device Name: | VANISHPOINT BLOOD COLLECTION SET |
| Classification | Set, Administration, Intravascular |
| 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 | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-30 |
| Decision Date | 2011-10-20 |
| Summary: | summary |