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 K022127
Device Name AVAGEN WOUND DRESSING
Applicant
Integra Lifesciences Corp.
311 Enterprise Dr.
Planisboro,  NJ  08536
Applicant Contact JUDITH E O'GRADY
Correspondent
Integra Lifesciences Corp.
311 Enterprise Dr.
Planisboro,  NJ  08536
Correspondent Contact JUDITH E O'GRADY
Classification Product Code
KGN  
Date Received07/01/2002
Decision Date 09/10/2002
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
-
-