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 K040403
Device Name COLLAGEN WOUND DRESSING - ORAL
Applicant
Collagen Matrix, Inc.
509 Commerce St.
Franklin Lakes,  NJ  07417
Applicant Contact PEGGY HANSEN
Correspondent
Collagen Matrix, Inc.
509 Commerce St.
Franklin Lakes,  NJ  07417
Correspondent Contact PEGGY HANSEN
Classification Product Code
KGN  
Date Received02/17/2004
Decision Date 05/10/2004
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
-
-