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 Wound Dressing With Animal-Derived Material(S)
510(k) Number K153690
Device Name PriMatrix Dermal Repair Scaffold
Applicant
Tei Biosciences, Inc.
7 Elkins St.
Boston,  MD  02127
Applicant Contact David D Cox
Correspondent
Integra Lifesciences Corp (Owner of Tei Biosciences)
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact David D Cox
Classification Product Code
KGN  
Date Received12/23/2015
Decision Date 02/22/2016
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
Recalls CDRH Recalls
-
-