FDA 510(k) Application Details - K992229

Device Classification Name System, X-Ray, Mobile

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510(K) Number K992229
Device Name System, X-Ray, Mobile
Applicant TREX MEDICAL CORP.
36 APPLE RIDGE RD.
DANBURY, CT 06810 US
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Contact KELVIN BURROUGHS
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Regulation Number 892.1720

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Classification Product Code IZL
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Date Received 07/02/1999
Decision Date 08/06/1999
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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