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 dressing, wound, drug
510(k) Number K003229
Device Name BIOPATCH ANTIMICROBIAL DRESSING
Applicant
INTEGRA LIFESCIENCES CORP.
ROUTE 22
SOMERVILLE,  NJ  08876
Applicant Contact WILLIAM GOELLER
Correspondent
INTEGRA LIFESCIENCES CORP.
ROUTE 22
SOMERVILLE,  NJ  08876
Correspondent Contact WILLIAM GOELLER
Classification Product Code
FRO  
Date Received10/10/2000
Decision Date 10/26/2001
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-