FDA 510(k) Application Details - K972130

Device Classification Name Camera, X-Ray, Fluorographic, Cine Or Spot

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510(K) Number K972130
Device Name Camera, X-Ray, Fluorographic, Cine Or Spot
Applicant FAIRMONT MEDICAL
4/21 MALVERN ST.
BAYSWATER, VICTORIA 3153 AU
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Contact JOANN MCBAIN
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Regulation Number 892.1620

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Classification Product Code IZJ
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Date Received 06/06/1997
Decision Date 10/09/1997
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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