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, Traction, Invasive
510(k) Number K981423
Device Name AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
Applicant
Autogenesis, Inc.
410 W. Lombard St., #217
Baltimore,  MD  21201
Applicant Contact JAMES EDWARDS
Correspondent
Autogenesis, Inc.
410 W. Lombard St., #217
Baltimore,  MD  21201
Correspondent Contact JAMES EDWARDS
Regulation Number888.3040
Classification Product Code
JEC  
Subsequent Product Code
HTY  
Date Received04/20/1998
Decision Date 05/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-