The following data is part of a premarket notification filed by Shandong Qiaopai Group Co., Ltd with the FDA for Model Tw Sb, Scalp Vein Set; Model Tw Lb, Sterile Hypodermic Needle.
| Device ID | K073705 |
| 510k Number | K073705 |
| Device Name: | MODEL TW SB, SCALP VEIN SET; MODEL TW LB, STERILE HYPODERMIC NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHANDONG QIAOPAI GROUP CO., LTD No.13,Qinghe Road,Gaoqing County Zibo, CN 256300 |
| Contact | Mark Job |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-12-31 |
| Decision Date | 2008-03-24 |