• 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 K120958
Device Name POSISEP AND POSISEP X HEMOSTAT DRESSINGS
Applicant
HEMOSTASIS, LLC
5000 township pkwy
saint paul,  MN  55110
Applicant Contact bernard horwath
Correspondent
HEMOSTASIS, LLC
5000 township pkwy
saint paul,  MN  55110
Correspondent Contact bernard horwath
Classification Product Code
FRO  
Date Received03/30/2012
Decision Date 07/25/2012
Decision substantially equivalent (SESE)
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-