• 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 Pin, Fixation, Smooth
510(k) Number K960642
Device Name NANCY NAIL
Applicant
Landos, Inc.
100 Lindenwood Dr.
Malvern,  PA  19355
Applicant Contact JEAN-PAUL BURTIN
Correspondent
Landos, Inc.
100 Lindenwood Dr.
Malvern,  PA  19355
Correspondent Contact JEAN-PAUL BURTIN
Regulation Number888.3040
Classification Product Code
HTY  
Date Received02/14/1996
Decision Date 05/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
-
-