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FDA 510(k) Application Details - K992818
Device Classification Name
Processor, Radiographic-Film, Automatic
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510(K) Number
K992818
Device Name
Processor, Radiographic-Film, Automatic
Applicant
PROTEC GMBH & CO. KG
LICHTENBERGER STR. 35
OBERSTENFELD 71720 DE
Other 510(k) Applications for this Company
Regulation Number
892.1900
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Classification Product Code
IXW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/20/1999
Decision Date
09/01/1999
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
Y
Expedited Review
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