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FDA 510(k) Application Details - K013886
Device Classification Name
System, Imaging, Holography, Acoustic
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510(K) Number
K013886
Device Name
System, Imaging, Holography, Acoustic
Applicant
ADVANCED DIAGNOSTICS, INC.
8112 304TH AVE. SE.
PRESTON, WA 98050 US
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Contact
STEVE HESSLER
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Regulation Number
000.0000
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Classification Product Code
NCS
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More FDA Info for this Product Code
Date Received
11/23/2001
Decision Date
05/10/2002
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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