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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 K112841
Device Name SURFACE BEACON TRANSPONDERS
Applicant
CALYPSO MEDICAL TECHNOLOGIES INC
2101 fourth ave
suite 500
seattle,  WA  98121
Contact marcia page
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/29/2011
Decision Date 02/16/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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