The following data is part of a premarket notification filed by Yidobio Inc. with the FDA for Caresens Pen Needle, Softip Pen Needle.
| Device ID | K160575 |
| 510k Number | K160575 |
| Device Name: | CareSens Pen Needle, Softip Pen Needle |
| Classification | Needle, Hypodermic, Single Lumen |
| Applicant | YIDOBIO INC. #3-1, 59-12, DONG4-GIL, HYANGNAM-EUP Hwaseong-si, KR 18624 |
| Contact | Kyung Hee Yoon |
| Correspondent | Kyung Hee Yoon YIDOBIO INC. #3-1, 59-12, DONG4-GIL, HYANGNAM-EUP Hwaseong-si, KR 18624 |
| Product Code | FMI |
| CFR Regulation Number | 880.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-01 |
| Decision Date | 2016-09-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20857513006388 | K160575 | 000 |
| 20857513006289 | K160575 | 000 |
| 20857513006296 | K160575 | 000 |
| 20857513006302 | K160575 | 000 |
| 20857513006333 | K160575 | 000 |
| 20857513006340 | K160575 | 000 |
| 20857513006357 | K160575 | 000 |
| 20857513006364 | K160575 | 000 |
| 20857513006371 | K160575 | 000 |
| 20857513006272 | K160575 | 000 |