The following data is part of a premarket notification filed by Gemtier Medical (shanghai) Inc. with the FDA for Safety Blood Collection Device For Single Use.
| Device ID | K170276 |
| 510k Number | K170276 |
| Device Name: | Safety Blood Collection Device For Single Use |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | Gemtier Medical (Shanghai) Inc. No.18 Jianding Road, Fengjing Town, Jinshan District, Shanghai, China Shanghai, CN 201502 |
| Contact | Lenny Cao |
| Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No. 26 Quinglan Street, Panyu Dis Guangzhou, CN 510006 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-30 |
| Decision Date | 2017-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20386120008909 | K170276 | 000 |
| 20386120008756 | K170276 | 000 |
| 20386120008749 | K170276 | 000 |
| 20386120008732 | K170276 | 000 |
| 20386120008725 | K170276 | 000 |
| 20386120008718 | K170276 | 000 |
| 20386120008701 | K170276 | 000 |
| 20386120008695 | K170276 | 000 |
| 20386120008688 | K170276 | 000 |
| 20386120008671 | K170276 | 000 |
| 20386120008664 | K170276 | 000 |
| 20386120008657 | K170276 | 000 |
| 20386120008763 | K170276 | 000 |
| 20386120008770 | K170276 | 000 |
| 20386120008787 | K170276 | 000 |
| 20386120008893 | K170276 | 000 |
| 20386120008886 | K170276 | 000 |
| 20386120008879 | K170276 | 000 |
| 20386120008862 | K170276 | 000 |
| 20386120008855 | K170276 | 000 |
| 20386120008848 | K170276 | 000 |
| 20386120008831 | K170276 | 000 |
| 20386120008824 | K170276 | 000 |
| 20386120008817 | K170276 | 000 |
| 20386120008800 | K170276 | 000 |
| 20386120008794 | K170276 | 000 |
| 20386120008640 | K170276 | 000 |