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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K083691
FOIA Releasable 510(k) K083691
Device Name BONEVUE
Applicant
Micromri, Inc.
580 Middletown Blvd.
Suite D-150
Langhorne,  PA  19047
Applicant Contact RICHARD ELRATH
Correspondent
Micromri, Inc.
580 Middletown Blvd.
Suite D-150
Langhorne,  PA  19047
Correspondent Contact RICHARD ELRATH
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/12/2008
Decision Date 02/25/2009
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
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