FDA 510(k) Application Details - K984414

Device Classification Name Collimator, Automatic, Radiographic

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510(K) Number K984414
Device Name Collimator, Automatic, Radiographic
Applicant TREX MEDICAL CORP.
300 FOSTER ST.
LITTLETON, MA 01460 US
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Contact WAYNE V LOOMER
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Regulation Number 892.1610

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Classification Product Code IZW
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Date Received 12/10/1998
Decision Date 12/30/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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