FDA 510(k) Application Details - K001140

Device Classification Name System, Image Processing, Radiological

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510(K) Number K001140
Device Name System, Image Processing, Radiological
Applicant SECTRA AB
2001 EAST OAKSHORES DR.
CROSSROADS, TX 76227 US
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Contact HERMAN OOSTERWIJK
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 04/10/2000
Decision Date 05/03/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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