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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 Echo, Ultrasonic
510(k) Number K022928
Device Name HUDSON 2020, 2040, 2060,ULTRASOUND SCANNERS
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 Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received09/04/2002
Decision Date 12/11/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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