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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
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