The following data is part of a premarket notification filed by Retractable Technologies, Inc. with the FDA for Easypoint Needle.
| Device ID | K133635 |
| 510k Number | K133635 |
| Device Name: | EASYPOINT NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| 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 | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-26 |
| Decision Date | 2014-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613703820921 | K133635 | 000 |
| 00613703850119 | K133635 | 000 |
| 00613703850218 | K133635 | 000 |
| 00613703850317 | K133635 | 000 |
| 00613703850416 | K133635 | 000 |
| 00613703850515 | K133635 | 000 |
| 00613703850614 | K133635 | 000 |
| 00613703850713 | K133635 | 000 |
| 00613703850812 | K133635 | 000 |
| 00613703850911 | K133635 | 000 |
| 00613703852113 | K133635 | 000 |
| 00613703852311 | K133635 | 000 |
| 00613703852915 | K133635 | 000 |
| 00613703820129 | K133635 | 000 |
| 00613703820327 | K133635 | 000 |
| 00613703822116 | K133635 | 000 |