The following data is part of a premarket notification filed by Wenzhou Wuzhou Group Co. Ltd. with the FDA for Wuzhou Syringe, With/without Needle.
| Device ID | K060211 |
| 510k Number | K060211 |
| Device Name: | WUZHOU SYRINGE, WITH/WITHOUT NEEDLE |
| Classification | Syringe, Piston |
| Applicant | WENZHOU WUZHOU GROUP CO. LTD. 1800 CENTURY PARK EAST SUITE 600 Los Angeles, CA 90067 |
| Contact | George Su |
| Correspondent | Laura Danielson TUV AMERICA, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-01-27 |
| Decision Date | 2006-02-10 |
| Summary: | summary |