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 Dressing, Wound, Drug
510(k) Number K160872
Device Name PolyPlex Wound Dressing
Applicant
Global Health Solutions, LLC
1360 Redmond Cir.
Rome,  GA  30165
Applicant Contact Bradley Burnam
Correspondent
Global Health Solutions, LLC
1360 Redmond Cir.
Rome,  GA  30165
Correspondent Contact Bradley Burnam
Classification Product Code
FRO  
Date Received03/30/2016
Decision Date 11/23/2016
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-