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 bandage, liquid
510(k) Number K950621
Device Name BIOFILL BIOCELLULOSE DRESSING STERILE
Applicant
THE PURDUE FREDERICK CO.
100 CONNECTICUT AVE.
NORWALK,  CT  06850 -3590
Applicant Contact JAMES H CONOVER
Correspondent
THE PURDUE FREDERICK CO.
100 CONNECTICUT AVE.
NORWALK,  CT  06850 -3590
Correspondent Contact JAMES H CONOVER
Regulation Number880.5090
Classification Product Code
KMF  
Date Received02/10/1995
Decision Date 12/26/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-