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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 K904127
Device Name A2J TELEMETER
Applicant
A2j, Inc.
225 Industrial Ct.
Fredericksburg,  VA  22408
Applicant Contact OLIVIER JACQUEAU
Correspondent
A2j, Inc.
225 Industrial Ct.
Fredericksburg,  VA  22408
Correspondent Contact OLIVIER JACQUEAU
Regulation Number892.5780
Classification Product Code
IWE  
Date Received08/29/1990
Decision Date 01/04/1991
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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