FDA 510(k) Application Details - K002404

Device Classification Name Processor, Radiographic-Film, Automatic

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510(K) Number K002404
Device Name Processor, Radiographic-Film, Automatic
Applicant TEK MARKETING, INC.
98 RAILROAD DR.
WARMINSTER, PA 18974-1454 US
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Contact JOHN A HOPE
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Regulation Number 892.1900

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Classification Product Code IXW
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Date Received 08/07/2000
Decision Date 08/30/2000
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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