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FDA 510(k) Application Details - K091628
Device Classification Name
Processor, Radiographic-Film, Automatic
More FDA Info for this Device
510(K) Number
K091628
Device Name
Processor, Radiographic-Film, Automatic
Applicant
PROTEC GMBH & CO. KG
LICHTENBERGER STR. 35
OBERSTENFELD 71720 DE
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Contact
JOCHEN KRUPP
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Regulation Number
892.1900
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Classification Product Code
IXW
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More FDA Info for this Product Code
Date Received
06/04/2009
Decision Date
08/21/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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