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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solid State X-Ray Imager (Flat Panel/Digital Imager)
510(k) Number K093790
Device Name SIMONDR DRP
Applicant
Simondr, Inc.
3515 Marmenco Ct.
Baltimore,  MD  21230
Applicant Contact VALERIE LOHR
Correspondent
Simondr, Inc.
3515 Marmenco Ct.
Baltimore,  MD  21230
Correspondent Contact VALERIE LOHR
Regulation Number892.1680
Classification Product Code
MQB  
Date Received12/10/2009
Decision Date 04/05/2010
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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