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 Hemostatic Wound Dressing Without Thrombin Or Other Biologics
510(k) Number K072900
Device Name EXCELARREST FOAM
Applicant
Hemostasis, LLC
5000 Township Pkwy.
St. Paul,  MN  55110
Applicant Contact KEITH ROBERTS
Correspondent
Hemostasis, LLC
5000 Township Pkwy.
St. Paul,  MN  55110
Correspondent Contact KEITH ROBERTS
Classification Product Code
QSY  
Subsequent Product Code
LYA  
Date Received10/11/2007
Decision Date 10/26/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-