FDA 510(k) Application Details - K021113

Device Classification Name Cabinet,X-Ray System

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510(K) Number K021113
Device Name Cabinet,X-Ray System
Applicant FISCHER IMAGING CORP.
12300 NORTH GRANT ST.
DENVER, CO 80241-3120 US
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Contact SAMIR B PALIWAL
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Regulation Number 892.1680

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Classification Product Code MWP
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Date Received 04/05/2002
Decision Date 06/13/2002
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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