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FDA 510(k) Application Details - K011173
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K011173
Device Name
System, Image Processing, Radiological
Applicant
IMED SYSTEMS & CONSULTING, LLC.
4715 TRAIL COURT
WESTMINSTER, MD 21158 US
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Contact
KENNETH P BONNER
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
04/17/2001
Decision Date
07/11/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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