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 Coil, Magnetic Resonance, Specialty
510(k) Number K023084
Device Name MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL
Applicant
Medical Advances, Inc.
10437 Innovation Dr.
Milwaukee,  WI  53226
Applicant Contact ANTHONY DIETZLER
Correspondent
Medical Advances, Inc.
10437 Innovation Dr.
Milwaukee,  WI  53226
Correspondent Contact ANTHONY DIETZLER
Regulation Number892.1000
Classification Product Code
MOS  
Date Received09/17/2002
Decision Date 12/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-