The following data is part of a premarket notification filed by Shandong Caremed Medical Products Co., Ltd. with the FDA for Medt Pen Needle.
| Device ID | K152824 |
| 510k Number | K152824 |
| Device Name: | MEDT PEN NEEDLE |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | SHANDONG CAREMED MEDICAL PRODUCTS CO., LTD. (YANTAI) INDUSTRIAL PARK DING TAO COUNTY (THE EAST OF ZHANQIAN ROAD) Heze, CN 274100 |
| Contact | Lin Yanyan |
| Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O BOX 120-119 Shanghai, CN 200120 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-29 |
| Decision Date | 2016-03-07 |
| Summary: | summary |