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FDA 510(k) Application Details - K970908
Device Classification Name
Digitizer, Image, Radiological
More FDA Info for this Device
510(K) Number
K970908
Device Name
Digitizer, Image, Radiological
Applicant
HOWTEK, INC.
21 PARK AVE.
HUDSON, NH 03051 US
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Contact
M. RUSSELL LEONARD
Other 510(k) Applications for this Contact
Regulation Number
892.2030
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Classification Product Code
LMA
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More FDA Info for this Product Code
Date Received
03/11/1997
Decision Date
05/20/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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