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FDA 510(k) Application Details - K961160
Device Classification Name
Device, Digital Image Storage, Radiological
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510(K) Number
K961160
Device Name
Device, Digital Image Storage, Radiological
Applicant
BASE TEN SYSTEMS, INC.
ONE ELECTTONICS DR.
P.O. BOX 3151
TRENTON, NJ 08619 US
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Contact
RICHARD J FARRELLY
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Regulation Number
892.2010
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Classification Product Code
LMB
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More FDA Info for this Product Code
Date Received
03/22/1996
Decision Date
06/11/1996
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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