The following data is part of a premarket notification filed by Shandong Weigao Group Medical Polymer Co.,ltd. with the FDA for Blunt Fill Needle And Blunt Plastic Cannula.
| Device ID | K102328 |
| 510k Number | K102328 |
| Device Name: | BLUNT FILL NEEDLE AND BLUNT PLASTIC CANNULA |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-17 |
| Decision Date | 2011-05-13 |
| Summary: | summary |