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 Component, Cast
510(k) Number K910274
Device Name ARTIFLEX(TM)
Applicant
Beiersdorf, Inc.
360 Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
Applicant Contact VINCENT MILANO
Correspondent
Beiersdorf, Inc.
360 Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
Correspondent Contact VINCENT MILANO
Regulation Number888.5940
Classification Product Code
LGF  
Date Received01/23/1991
Decision Date 03/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-