The following data is part of a premarket notification filed by Shanghai Carelife International Trading Co., Ltd. with the FDA for Medi Pen Needle.
| Device ID | K131954 |
| 510k Number | K131954 |
| Device Name: | MEDI PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHANGHAI CARELIFE INTERNATIONAL TRADING CO., LTD. ROOM 1707, YINQIAO BLDG, NO 58 JINXIN ROAD Shanghai, Pudong, CN 201206 |
| Contact | William Conety |
| Correspondent | William Conety SHANGHAI CARELIFE INTERNATIONAL TRADING CO., LTD. ROOM 1707, YINQIAO BLDG, NO 58 JINXIN ROAD Shanghai, Pudong, CN 201206 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2014-05-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00616784702834 | K131954 | 000 |
| 00616784702735 | K131954 | 000 |
| 00616784702636 | K131954 | 000 |
| 00616784702537 | K131954 | 000 |
| 00616784702438 | K131954 | 000 |