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 K200767
Device Name SilverStream Gel
Applicant
Enzysurge , Ltd.
26 Shabazi St.
Rosh Ha'Ayin,  IL 4802126
Applicant Contact Moshe Landsberg
Correspondent
Bioreg Services
6 Beit Hashoeva St.
Jerusalem,  IL 9751723
Correspondent Contact Daniel Albahari
Classification Product Code
FRO  
Date Received03/25/2020
Decision Date 10/08/2020
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
-
-