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 |