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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Mobile
510(k) Number K850678
Device Name AIM N' SHOOT - AUTOMATIC EXPOSURE CONTROL
Applicant
Fairchild Medical Systems, Inc.
79 Tosca Dr.
Stoughton,  MA  02072
Applicant Contact RICHARD A FAIRCHILD
Correspondent
Fairchild Medical Systems, Inc.
79 Tosca Dr.
Stoughton,  MA  02072
Correspondent Contact RICHARD A FAIRCHILD
Regulation Number892.1720
Classification Product Code
IZL  
Date Received02/21/1985
Decision Date 04/18/1985
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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