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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Charged-Particle, Medical
510(k) Number K102373
Device Name CALYPSO SYSTEM WITH DYNAMIC EDGE GATING
Applicant
Calypso Medical Technologies, Inc.
2101 Fourth Ave., Suite 500
Seattle,  WA  98121
Applicant Contact ED VERTATSCHITSCH
Correspondent
Calypso Medical Technologies, Inc.
2101 Fourth Ave., Suite 500
Seattle,  WA  98121
Correspondent Contact ED VERTATSCHITSCH
Regulation Number892.5050
Classification Product Code
LHN  
Date Received08/20/2010
Decision Date 09/30/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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