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 Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
510(k) Number K944132
Device Name P.F.C. TOTAL HIP SYSTEM
Applicant
Johnson & Johnson Professionals, Inc.
Brunel Way
Slough, Berks
England,  GB SL1 IXR
Applicant Contact PATRICIA BANKERT
Correspondent
Johnson & Johnson Professionals, Inc.
Brunel Way
Slough, Berks
England,  GB SL1 IXR
Correspondent Contact PATRICIA BANKERT
Regulation Number888.3390
Classification Product Code
KWY  
Subsequent Product Code
LPH  
Date Received08/24/1994
Decision Date 01/06/1995
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
-
-