FDA 510(k) Application Details - K961022

Device Classification Name Table, Radiographic, Tilting

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510(K) Number K961022
Device Name Table, Radiographic, Tilting
Applicant FISCHER IMAGING CORP.
12300 NORTH GRANT ST.
DENVER, CO 80241-3120 US
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Contact SAMUELLA D EMRICH
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Regulation Number 892.1980

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Classification Product Code IXR
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Date Received 03/14/1996
Decision Date 05/03/1996
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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