The following data is part of a premarket notification filed by Cpl Co., Ltd. with the FDA for Cpl Insulin Pen Needle.
| Device ID | K151090 |
| 510k Number | K151090 |
| Device Name: | CPL Insulin Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | CPL CO., LTD. 36, YONGTEURIM-GIL, DANWON-GU Ansan, KP 425-430 |
| Contact | Choi Kyoung Soo |
| 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 | 2015-04-23 |
| Decision Date | 2016-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800062763736 | K151090 | 000 |