The following data is part of a premarket notification filed by Medexel Co., Ltd. with the FDA for Top Fine Pen Needle.
| Device ID | K152410 |
| 510k Number | K152410 |
| Device Name: | Top Fine Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | MEDEXEL CO., LTD. 252, GEUMGWANGOSAN-RO, GUEMGWANG-MYEON Anseong-si, KR 17535 |
| Contact | Cha Dong Ik |
| Correspondent | Peter Chung PLUS GLOBAL 300 ATWOOD Pittsburgh, PA 15213 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-26 |
| Decision Date | 2016-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28809445832094 | K152410 | 000 |
| 08809445831895 | K152410 | 000 |
| 18809445831885 | K152410 | 000 |
| 18809445831878 | K152410 | 000 |
| 18809445831854 | K152410 | 000 |
| 18809445831847 | K152410 | 000 |
| 18809445831830 | K152410 | 000 |
| 18809445831823 | K152410 | 000 |
| 18809445831816 | K152410 | 000 |
| 18809445831809 | K152410 | 000 |
| 18809445831793 | K152410 | 000 |
| 18809445831786 | K152410 | 000 |
| 18809445831908 | K152410 | 000 |
| 18809445831915 | K152410 | 000 |
| 18809445832073 | K152410 | 000 |
| 18809445832011 | K152410 | 000 |
| 18809445832004 | K152410 | 000 |
| 18809445831991 | K152410 | 000 |
| 18809445831984 | K152410 | 000 |
| 18809445831977 | K152410 | 000 |
| 18809445831960 | K152410 | 000 |
| 18809445831953 | K152410 | 000 |
| 18809445831946 | K152410 | 000 |
| 18809445831939 | K152410 | 000 |
| 18809445831922 | K152410 | 000 |
| 18809445831779 | K152410 | 000 |