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 Absorbable Synthetic Wound Dressing
510(k) Number K251567
Device Name NovoSorb BTM
Applicant
Polynovo Biomaterials Pty, Ltd.
2/320 Lorimer St.
Port Melbourne
Melbourne,  AU 3207
Applicant Contact Shruti Dave
Correspondent
Polynovo Biomaterials Pty, Ltd.
2/320 Lorimer St.
Port Melbourne
Melbourne,  AU 3207
Correspondent Contact Shruti Dave
Classification Product Code
QSZ  
Date Received05/22/2025
Decision Date 06/20/2025
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
-
-