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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Patient Position, Light-Beam
510(k) Number K931974
Device Name AZ 92
Applicant
A2j, Inc.
225 Industrial Ct.
Fredericksburg,  VA  22408
Applicant Contact JIM L.
Correspondent
A2j, Inc.
225 Industrial Ct.
Fredericksburg,  VA  22408
Correspondent Contact JIM L.
Regulation Number892.5780
Classification Product Code
IWE  
Date Received04/22/1993
Decision Date 10/08/1993
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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