The following data is part of a premarket notification filed by Weihai Hongyu Medical Devices Co., Ltd. with the FDA for Disposable Bllod Collection Needle.
| Device ID | K103587 |
| 510k Number | K103587 |
| Device Name: | DISPOSABLE BLLOD COLLECTION NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | WEIHAI HONGYU MEDICAL DEVICES CO., LTD. P.O. BOX 237-023 Shanghai, CN 264200 |
| Contact | Diana Hong |
| Correspondent | Diana Hong WEIHAI HONGYU MEDICAL DEVICES CO., LTD. P.O. BOX 237-023 Shanghai, CN 264200 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-07 |
| Decision Date | 2011-04-06 |
| Summary: | summary |