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 |