The following data is part of a premarket notification filed by Shandong Weigao Group Medical Polymer Co.,ltd. with the FDA for Blood Collection Needle, Model 20g 21g 22g.
| Device ID | K073127 |
| 510k Number | K073127 |
| Device Name: | BLOOD COLLECTION NEEDLE, MODEL 20G 21G 22G |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong SHANDONG WEIGAO GROUP MEDICAL POLYMER CO.,LTD. SUITE 8D, NO.19, LANE 999 ZHONGSHAN NO.2 ROAD(S) Shanghai, CN 200030 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-06 |
| Decision Date | 2007-12-20 |
| Summary: | summary |