The following data is part of a premarket notification filed by Shanghai Kindly Enterprise Dev. Group Co., with the FDA for Kdl Syringes And Needle.
Device ID | K112057 |
510k Number | K112057 |
Device Name: | KDL SYRINGES AND NEEDLE |
Classification | Syringe, Piston |
Applicant | SHANGHAI KINDLY ENTERPRISE DEV. GROUP CO., P.O. BOX 237-023 Shanghai, CN 200237 |
Contact | Diana Hong |
Correspondent | Diana Hong SHANGHAI KINDLY ENTERPRISE DEV. GROUP CO., P.O. BOX 237-023 Shanghai, CN 200237 |
Product Code | FMF |
CFR Regulation Number | 880.5860 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-07-19 |
Decision Date | 2011-12-14 |
Summary: | summary |