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 K000051
Device Name ACTICOAT FOAM DRESSING
Applicant
WESTAIM BIOMEDICAL, INC.
ONE HAMPTON RD.
SUITE 302
EXETER,  NH  03833
Applicant Contact Steve Chartier
Correspondent
WESTAIM BIOMEDICAL, INC.
ONE HAMPTON RD.
SUITE 302
EXETER,  NH  03833
Correspondent Contact Steve Chartier
Classification Product Code
FRO  
Date Received01/07/2000
Decision Date 04/05/2000
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-