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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTESLACON(TM) NMR IMAGING SYSTEM
Generic NameSystem, nuclear magnetic resonance imaging
Regulation Number892.1000
ApplicantTechnicare Corp.
P.O. Box 5130
Cleveland, OH 44101
PMA NumberP830051
Supplement NumberS012
Date Received08/18/1986
Decision Date11/05/1986
Product Code LNH 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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