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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assembly, Tube Housing, X-Ray, Diagnostic
510(k) Number K860760
Device Name ERBIUM X-RAY FILTER
Applicant
Reactor Experiments, Inc.
963 Terminal Way
San Carlos,  CA  94070
Applicant Contact BRUCE A HEIMAN
Correspondent
Reactor Experiments, Inc.
963 Terminal Way
San Carlos,  CA  94070
Correspondent Contact BRUCE A HEIMAN
Regulation Number892.1760
Classification Product Code
ITY  
Date Received02/28/1986
Decision Date 06/10/1986
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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