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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, nuclear magnetic resonance imaging
510(k) Number K001773
Device Name ORTHONE
Applicant
ONI, INC.
790 TURNPIKE STREET, STE 100
NORTH ANDOVER,  MA  01845
Applicant Contact MICHAEL A DOUGLAS
Correspondent
ONI, INC.
790 TURNPIKE STREET, STE 100
NORTH ANDOVER,  MA  01845
Correspondent Contact MICHAEL A DOUGLAS
Regulation Number892.1000
Classification Product Code
LNH  
Date Received06/12/2000
Decision Date 08/18/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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