The following data is part of a premarket notification filed by Y. Jacobs Medical, Inc. with the FDA for J+pras Young's Thread.
| Device ID | K143413 |
| 510k Number | K143413 |
| Device Name: | J+PRAS YOUNG'S Thread |
| Classification | Suture, Surgical, Absorbable, Polydioxanone |
| Applicant | Y. Jacobs Medical, Inc. 6F Sangkyeong Bldg. 669 Seolleung-ro, Gangnam-gu Seoul, KR 135830 |
| Contact | Joo Hwan Jeon |
| Correspondent | Meredith May Qserve Group US Inc. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | NEW |
| CFR Regulation Number | 878.4840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-28 |
| Decision Date | 2015-09-11 |