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FDA 510(k) Application Details - K021072
Device Classification Name
System, Image Processing, Radiological
More FDA Info for this Device
510(K) Number
K021072
Device Name
System, Image Processing, Radiological
Applicant
AMERICAN MEDICAL RESOURCES, LTD. (AMR)
3501 SILVERSIDE RD. SUITE 205
WILMINGTON, DE 19810 US
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Contact
ELIZABETH N FAULSTICH
Other 510(k) Applications for this Contact
Regulation Number
892.2050
More FDA Info for this Regulation Number
Classification Product Code
LLZ
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More FDA Info for this Product Code
Date Received
04/02/2002
Decision Date
06/06/2002
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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