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 Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K153017
Device Name Voyant Fine Fusion
Applicant
Applied Medical Resources
22872 Avenida Empresa
Rancho Santa,  CA  92688
Applicant Contact JESSICA CHO
Correspondent
Applied Medical Resources
22872 Avenida Empresa
Rancho Santa,  CA  92688
Correspondent Contact JESSICA CHO
Regulation Number878.4400
Classification Product Code
GEI  
Date Received10/15/2015
Decision Date 07/06/2016
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
-
-