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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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More FDA Info for this Product Code
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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