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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K052023
Device Name CADIMAS VERSION 1.0
Applicant
Alan Penn & Associates., Inc.
6319 Massachusetts Ave.
Bethesda,  MD  20816 -1139
Applicant Contact ROGER H SCHNEIDER
Correspondent
Alan Penn & Associates., Inc.
6319 Massachusetts Ave.
Bethesda,  MD  20816 -1139
Correspondent Contact ROGER H SCHNEIDER
Regulation Number892.1000
Classification Product Code
LNH  
Subsequent Product Code
LLZ  
Date Received07/26/2005
Decision Date 12/08/2005
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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