The following data is part of a premarket notification filed by Thinkmed Medical Technology Co., Ltd. with the FDA for Tm Safety Needle.
| Device ID | K142765 |
| 510k Number | K142765 |
| Device Name: | TM SAFETY NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | ThinkMed Medical Technology Co., Ltd. No.4 Building, 322 Hongyang Road, Qiandeng Town Kunshan, CN 215341 |
| Contact | Garfield Wang |
| Correspondent | Garfield Wang ThinkMed Medical Technology Co., Ltd. No.4 Building, 322 Hongyang Road, Qiandeng Town Kunshan, CN 215341 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-25 |
| Decision Date | 2015-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784897622 | K142765 | 000 |
| G002UUSF2510SN0 | K142765 | 000 |
| G002UUSF2310SN0 | K142765 | 000 |
| G002FUSF2510SN0 | K142765 | 000 |
| UUSF2231SN0 | K142765 | 000 |
| G001N25151 | K142765 | 000 |
| G001N25101 | K142765 | 000 |
| G001N23150 | K142765 | 000 |
| G001N23101 | K142765 | 000 |
| G001N21150 | K142765 | 000 |
| 10732671106039 | K142765 | 000 |
| 10732671106022 | K142765 | 000 |
| 10732671106015 | K142765 | 000 |
| 00616784896021 | K142765 | 000 |
| 00616784896229 | K142765 | 000 |
| 00616784896328 | K142765 | 000 |
| 00616784897523 | K142765 | 000 |
| 00616784897424 | K142765 | 000 |
| 00616784897325 | K142765 | 000 |
| 00616784897226 | K142765 | 000 |
| 00616784897127 | K142765 | 000 |
| 00616784897028 | K142765 | 000 |
| 00616784896922 | K142765 | 000 |
| 00616784896823 | K142765 | 000 |
| 00616784896724 | K142765 | 000 |
| 00616784896625 | K142765 | 000 |
| 00616784896526 | K142765 | 000 |
| 00616784896427 | K142765 | 000 |
| 00732671006004 | K142765 | 000 |