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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name accelerator, linear, medical
510(k) Number K092479
Device Name SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL
Applicant
DYN'R
73 RUE LOUGE
MURET,  FR 31600
Applicant Contact XAVIER ISNARD
Correspondent
DYN'R
73 RUE LOUGE
MURET,  FR 31600
Correspondent Contact XAVIER ISNARD
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/13/2009
Decision Date 01/11/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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