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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 K902965
Device Name FDI 2000 ULTRASONIC SKIN SCANNER
Applicant
Fulmer Dyson Intl.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Applicant Contact LYNNE ARONSON
Correspondent
Fulmer Dyson Intl.
45 W. St.
Suite 2
North Attleboro,  MA  02703
Correspondent Contact LYNNE ARONSON
Regulation Number892.1560
Classification Product Code
IYO  
Date Received07/06/1990
Decision Date 09/26/1990
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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