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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 K970564
Device Name DYNAMIC WEDGE
Applicant
Mitsubishi Electronics America, Inc.
12300 Twinbook Pkwy., #625
Rockville,  MD  20852
Applicant Contact T. WHIT ATHEY
Correspondent
Mitsubishi Electronics America, Inc.
12300 Twinbook Pkwy., #625
Rockville,  MD  20852
Correspondent Contact T. WHIT ATHEY
Regulation Number892.5050
Classification Product Code
IYE  
Date Received02/13/1997
Decision Date 05/12/1997
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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