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FDA 510(k) Application Details - K963893
Device Classification Name
Grid, Radiographic
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510(K) Number
K963893
Device Name
Grid, Radiographic
Applicant
SMIT RONTGEN
POSTBOX 218
MD EINDHOVEN 5600 NL
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Contact
ING. R.W. RIJNTJES
Other 510(k) Applications for this Contact
Regulation Number
892.1910
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Classification Product Code
IXJ
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More FDA Info for this Product Code
Date Received
09/27/1996
Decision Date
11/07/1996
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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