The following data is part of a premarket notification filed by Wenzhou Wuzhou Import & Export Co., Ltd with the FDA for Insulin Pen Needle.
| Device ID | K133058 |
| 510k Number | K133058 |
| Device Name: | INSULIN PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | WENZHOU WUZHOU IMPORT & EXPORT CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong WENZHOU WUZHOU IMPORT & EXPORT 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 |
|---|---|---|
| 00372217006121 | K133058 | 000 |
| 16958697605866 | K133058 | 000 |
| 16958697605859 | K133058 | 000 |
| 16958697605842 | K133058 | 000 |
| 16958697605828 | K133058 | 000 |
| 26958697605924 | K133058 | 000 |
| 26958697605917 | K133058 | 000 |
| 26958697605900 | K133058 | 000 |
| 26958697605894 | K133058 | 000 |
| 16958697605873 | K133058 | 000 |
| 10860003125516 | K133058 | 000 |
| 10850632007468 | K133058 | 000 |
| 10850632007451 | K133058 | 000 |
| 10850632007444 | K133058 | 000 |
| 20858835007985 | K133058 | 000 |
| 00372217006114 | K133058 | 000 |
| 10860003125547 | K133058 | 000 |
| 10860003125530 | K133058 | 000 |
| 10860003125523 | K133058 | 000 |
| 26958697605887 | K133058 | 000 |