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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 St., Suite 100
North Andover,  MA  01845
Applicant Contact MICHAEL A DOUGLAS
Correspondent
Oni, Inc.
790 Turnpike St., Suite 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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