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 And Burn, Occlusive
510(k) Number K973657
Device Name ARGLAES-AB ANTIMICROBIAL BARRIER ISLAND DRESSING
Applicant
Maersk Medical, Ltd.
7527 Westmoreland Ave.
St Louis,  MO  63105
Applicant Contact EVAN DICK
Correspondent
Maersk Medical, Ltd.
7527 Westmoreland Ave.
St Louis,  MO  63105
Correspondent Contact EVAN DICK
Classification Product Code
MGP  
Date Received09/25/1997
Decision Date 12/01/1997
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-