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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Doppler, Ultrasonic
510(k) Number K040926
Device Name ULTRASOUND SCANNER, HUDSON MODELS 8000 AND 9000
Applicant
Hudson Diagnostic Imaging, LLC
610 Blvd.
Elmwood Park,  NJ  07407
Applicant Contact MARTIN E WENDELKEN
Correspondent
Hudson Diagnostic Imaging, LLC
610 Blvd.
Elmwood Park,  NJ  07407
Correspondent Contact MARTIN E WENDELKEN
Regulation Number892.1550
Classification Product Code
IYN  
Subsequent Product Codes
ITX   IYO  
Date Received04/08/2004
Decision Date 06/10/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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