The following data is part of a premarket notification filed by Wenzhou Wuzhou Import & Export Co., Ltd with the FDA for Disposable Insulin Syringe.
| Device ID | K110421 |
| 510k Number | K110421 |
| Device Name: | DISPOSABLE INSULIN SYRINGE |
| Classification | Syringe, Piston |
| Applicant | WENZHOU WUZHOU IMPORT & EXPORT CO., LTD P.O. BOX 237-023 Bingyi Xiang, Zhejiang, CN 325000 |
| Contact | Diana Hong |
| Correspondent | Diana Hong WENZHOU WUZHOU IMPORT & EXPORT CO., LTD P.O. BOX 237-023 Bingyi Xiang, Zhejiang, CN 325000 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-14 |
| Decision Date | 2011-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B2086345633 | K110421 | 000 |
| 10850632007413 | K110421 | 000 |
| 10850632007406 | K110421 | 000 |
| 00858835007394 | K110421 | 000 |
| 20858835007367 | K110421 | 000 |
| 20858835007190 | K110421 | 000 |
| 20858835007169 | K110421 | 000 |
| 10812460026776 | K110421 | 000 |
| 10812460026752 | K110421 | 000 |
| 10812460026738 | K110421 | 000 |
| 10812460026707 | K110421 | 000 |
| 10812460026837 | K110421 | 000 |
| B2086295013 | K110421 | 000 |
| B2086295030 | K110421 | 000 |
| B2086295053 | K110421 | 000 |
| B2086345033 | K110421 | 000 |
| B2086325633 | K110421 | 000 |
| B2086315653 | K110421 | 000 |
| B2086315633 | K110421 | 000 |
| B2086315613 | K110421 | 000 |
| B2086305653 | K110421 | 000 |
| B2086305633 | K110421 | 000 |
| B2086305613 | K110421 | 000 |
| B2086305053 | K110421 | 000 |
| B2086305033 | K110421 | 000 |
| B2086305013 | K110421 | 000 |
| 10812460026806 | K110421 | 000 |