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 |