FDA 510(k) Application Details - K024085

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

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510(K) Number K024085
Device Name Camera, X-Ray, Fluorographic, Cine Or Spot
Applicant PERKINS ELECTRONICS CO.
1510 N.WASHINGTON AVE.
DALLAS, TX 75204-5297 US
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Contact JIM FURSE
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Regulation Number 892.1620

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Classification Product Code IZJ
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Date Received 12/11/2002
Decision Date 03/11/2003
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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