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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Digitizer, Image, Radiological
510(k) Number K021949
Device Name FULCRUM
Applicant
HOWTEK, INC.
21 PARK AVE.
HUDSON,  NH  03051
Applicant Contact JOHN E ROSENSTENGEL
Correspondent
HOWTEK, INC.
21 PARK AVE.
HUDSON,  NH  03051
Correspondent Contact JOHN E ROSENSTENGEL
Regulation Number892.2030
Classification Product Code
LMA  
Date Received06/13/2002
Decision Date 08/12/2002
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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