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FDA 510(k) Application Details - K993532
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K993532
Device Name
System, Image Processing, Radiological
Applicant
IMPAX TECHNOLOGY, INC.
455 PHILLIP ST.
WATERLOO, ONTARIO N2L 3X2 CA
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Contact
PAULA PFEIFLE
Other 510(k) Applications for this Contact
Regulation Number
892.2050
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Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
10/19/1999
Decision Date
12/15/1999
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
N
Expedited Review
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