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 K133775
Device Name EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING
Applicant
Exciton Technologies, Inc.
Suite 4000, 10230 Jasper Ave.
Edmonton, Alberta,  CA T5Z 3N5
Applicant Contact MELANIE USSYK
Correspondent
Exciton Technologies, Inc.
Suite 4000, 10230 Jasper Ave.
Edmonton, Alberta,  CA T5Z 3N5
Correspondent Contact MELANIE USSYK
Classification Product Code
FRO  
Date Received12/12/2013
Decision Date 03/26/2014
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
-
-