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 K072113
Device Name INTEGRA FLOWABLE WOUND MATRIX, MODEL FWD301
Applicant
INTEGRA LIFESCIENCES CORP.
311C ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Applicant Contact DIANA M BORDON
Correspondent
INTEGRA LIFESCIENCES CORP.
311C ENTERPRISE DRIVE
PLAINSBORO,  NJ  08536
Correspondent Contact DIANA M BORDON
Classification Product Code
KGN  
Date Received08/01/2007
Decision Date 10/10/2007
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-