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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 K882939
Device Name NIOBI-X RADIATION REDUCTION FILTER
Applicant
American Canadian Products, Inc.
10014 N. Dale Mabry Suite
101
Tampa,  FL  33618
Applicant Contact NICHOLAS I FARRIS
Correspondent
American Canadian Products, Inc.
10014 N. Dale Mabry Suite
101
Tampa,  FL  33618
Correspondent Contact NICHOLAS I FARRIS
Regulation Number892.1760
Classification Product Code
ITY  
Date Received07/13/1988
Decision Date 11/04/1988
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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