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
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Regulation Number 892.1910

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Classification Product Code IXJ
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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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