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FDA 510(k) Application Details - K973411
Device Classification Name
Digitizer, Image, Radiological
More FDA Info for this Device
510(K) Number
K973411
Device Name
Digitizer, Image, Radiological
Applicant
GENERAL SCANNING, INC.
500 ARSENAL ST.
WATERTOWN, MA 02172 US
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Contact
WALTER J LESLIE
Other 510(k) Applications for this Contact
Regulation Number
892.2030
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Classification Product Code
LMA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/09/1997
Decision Date
12/04/1997
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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