The following data is part of a premarket notification filed by W. L. Med Co., Ltd. with the FDA for Well-life Tm Pen Needles, Well-life Tm Safety Pen Needles.
| Device ID | K210748 |
| 510k Number | K210748 |
| Device Name: | Well-life TM Pen Needles, Well-life TM Safety Pen Needles |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | W. L. Med Co., Ltd. 246, Geumgwangosan-ro, Geumgwang-yeon Anseong-si, KR 17535 |
| Contact | Ha Tae Joo |
| Correspondent | Peter Chung Plus Global 300, Atwood Street 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 | 2021-03-12 |
| Decision Date | 2022-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800186704493 | K210748 | 000 |
| 08800186704226 | K210748 | 000 |
| 08800186704288 | K210748 | 000 |
| 08800186704318 | K210748 | 000 |
| 08800186704349 | K210748 | 000 |
| 08800186704370 | K210748 | 000 |
| 08800186704400 | K210748 | 000 |
| 08800186704431 | K210748 | 000 |
| 08800186704462 | K210748 | 000 |
| 08800186704257 | K210748 | 000 |