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 K850147
Device Name CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE
Applicant
Beiersdorf, Inc.
360 Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
Applicant Contact JOHN TREMBLEY
Correspondent
Beiersdorf, Inc.
360 Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
Correspondent Contact JOHN TREMBLEY
Classification Product Code
FRO  
Date Received01/14/1985
Decision Date 07/05/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-