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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 K080726
Device Name CALYPSO 4D LOCALIZATION SYSTEM
Applicant
Calypso Medical Technologies, Inc.
2101 Fourth Ave., Suite 500
Seattle,  WA  98121
Applicant Contact ERIC MEIER
Correspondent
Calypso Medical Technologies, Inc.
2101 Fourth Ave., Suite 500
Seattle,  WA  98121
Correspondent Contact ERIC MEIER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received03/14/2008
Decision Date 05/14/2008
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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