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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 K925714
Device Name BREAST SIMULATION SYSTEM
Applicant
Severn Research, Inc.
2706 Post Oak Ct.
Annapolis,  MD  21401
Applicant Contact LINDA K SIDDON
Correspondent
Severn Research, Inc.
2706 Post Oak Ct.
Annapolis,  MD  21401
Correspondent Contact LINDA K SIDDON
Regulation Number892.5050
Classification Product Code
IYE  
Date Received11/12/1992
Decision Date 06/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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