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 K150553
Device Name Filbloc
Applicant
Assut Europe
Zona Industriale
Magliano Dei Marsi,  IT 1-67062
Applicant Contact GLORIA AGGIO
Correspondent
Registrar Corp.
144 Research Dr.
Hampton,  VA  23666
Correspondent Contact RHONDA ALEXANDER
Regulation Number878.4840
Classification Product Code
NEW  
Date Received03/04/2015
Decision Date 05/19/2016
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
-
-