The following data is part of a premarket notification filed by Retractable Technologies, Inc. with the FDA for Easypoint Blood Collection Plus.
| Device ID | K202325 |
| 510k Number | K202325 |
| Device Name: | EasyPoint Blood Collection Plus |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | Retractable Technologies, Inc. 511 Lobo Lane Little Elm, TX 75068 |
| Contact | Becky Piroga |
| Correspondent | Becky Piroga Retractable Technologies, Inc. 511 Lobo Lane 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 | 2020-08-17 |
| Decision Date | 2021-04-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613703260215 | K202325 | 000 |
| 00613703260116 | K202325 | 000 |