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 K220566
Device Name Vascette HP (hemostatic pad)
Applicant
Koag, LLC
790 Rarity Bay Pkwy.
Vonore,  TN  37885
Applicant Contact David Lang
Correspondent
Koag, LLC
790 Rarity Bay Pkwy.
Vonore,  TN  37885
Correspondent Contact David Lang
Classification Product Code
QSY  
Date Received02/28/2022
Decision Date 07/29/2022
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-