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 |