Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K143413
Device Name J+PRAS YOUNG'S Thread
Applicant
Y. Jacobs Medical, Inc.
6f Sangkyeong Bldg. 669 Seolleung-Ro, Gangnam-Gu
Seoul,  KR 135830
Applicant Contact Joo Hwan Jeon
Correspondent
Qserve Group, Us, Inc.
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith May
Regulation Number878.4840
Classification Product Code
NEW  
Date Received11/28/2014
Decision Date 09/11/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-