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 K163430
Device Name Prontosan Wound Gel
Applicant
B. Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109 -9341
Applicant Contact Nancy Skocypec
Correspondent
B. Braun Medical, Inc.
901 Marcon Blvd.
Allentown,  PA  18109 -9341
Correspondent Contact Nancy Skocypec
Classification Product Code
FRO  
Date Received12/07/2016
Decision Date 05/23/2017
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
-
-