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 Endoscopic Tissue Approximation Device
510(k) Number K160117
Device Name AbClose - Port Site Closure Device
Applicant
Medeon Biodesign, Inc.
7f, 116, Hougang St.,
Taipei,  TW 11170
Applicant Contact GRETA CHANG
Correspondent
Medeon Biodesign, Inc.
7f, 116, Hougang St.,
Taipei,  TW 11170
Correspondent Contact Greta Chang
Regulation Number876.1500
Classification Product Code
OCW  
Subsequent Product Codes
GCJ   HCF  
Date Received01/19/2016
Decision Date 09/09/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-