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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
Original Applicant
CALYPSO MEDICAL TECHNOLOGIES INC
2101 fourth ave
suite 500
seattle,  WA  98121
Original Contact marcia page
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/29/2011
Decision Date 02/16/2012
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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