FDA 510(k) Application Details - K001510

Device Classification Name System, Imaging, Holography, Acoustic

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510(K) Number K001510
Device Name System, Imaging, Holography, Acoustic
Applicant ADVANCED DIAGNOSTICS, INC.
2400 STEVENS DR., SUITE C
RICHLAND, WA 98126 US
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Contact STEVE HESLER
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Regulation Number 000.0000

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Classification Product Code NCS
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Date Received 05/15/2000
Decision Date 11/30/2000
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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