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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 K871227
Device Name LES RAD FILTER
Applicant
M. D. Products
2137 SE Fort King
Ocala,  FL  32671
Applicant Contact DREYFUS, DDS
Correspondent
M. D. Products
2137 SE Fort King
Ocala,  FL  32671
Correspondent Contact DREYFUS, DDS
Regulation Number892.1760
Classification Product Code
ITY  
Date Received03/27/1987
Decision Date 06/29/1987
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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