The following data is part of a premarket notification filed by Wenzhou Beipu Science & Technology Co., Ltd. with the FDA for Insulin Pen Needle.
| Device ID | K133059 |
| 510k Number | K133059 |
| Device Name: | INSULIN PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | WENZHOU BEIPU SCIENCE & TECHNOLOGY CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong WENZHOU BEIPU SCIENCE & TECHNOLOGY CO., LTD. P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-27 |
| Decision Date | 2014-02-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00372217006077 | K133059 | 000 |
| 06949236200447 | K133059 | 000 |
| 06949236200430 | K133059 | 000 |
| 06949236200423 | K133059 | 000 |
| 06949236200416 | K133059 | 000 |
| 06949236200409 | K133059 | 000 |
| 06949236200393 | K133059 | 000 |
| 06949236200386 | K133059 | 000 |
| 06949236200379 | K133059 | 000 |
| 06949236200362 | K133059 | 000 |
| B7443357763 | K133059 | 000 |
| B7443357743 | K133059 | 000 |
| B7443357733 | K133059 | 000 |
| B7443357723 | K133059 | 000 |
| 06949236200454 | K133059 | 000 |
| 06949236200461 | K133059 | 000 |
| 00372217006060 | K133059 | 000 |
| 00372217006053 | K133059 | 000 |
| 00372217006046 | K133059 | 000 |
| 00372217006039 | K133059 | 000 |
| 00372217006022 | K133059 | 000 |
| 00372217006015 | K133059 | 000 |
| 06949236200539 | K133059 | 000 |
| 06949236200522 | K133059 | 000 |
| 06949236200515 | K133059 | 000 |
| 06949236200508 | K133059 | 000 |
| 06949236200492 | K133059 | 000 |
| 06949236200485 | K133059 | 000 |
| 06949236200478 | K133059 | 000 |
| B7443357713 | K133059 | 000 |