The following data is part of a premarket notification filed by Y. Jacobs Medical, Inc with the FDA for Y.jacobs Young's Thread Synthetic Absorbable Surgical Fixation Suture,.
Device ID | K160705 |
510k Number | K160705 |
Device Name: | Y.JACOBS YOUNG'S THREAD Synthetic Absorbable Surgical Fixation Suture, |
Classification | Suture, Surgical, Absorbable, Polydioxanone |
Applicant | Y. JACOBS MEDICAL, INC 6F SANGKYUNG BLDG. 669 SEOLLEUNG-RO GANGNAM-GU Seoul, KR 135-830 |
Contact | Hui Jun Park |
Correspondent | Meredith May EMPIRICAL TESTING 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 | 2016-03-14 |
Decision Date | 2016-11-23 |
Summary: | summary |