FDA 510(k) Application Details - K991282

Device Classification Name Camera, Multi Format, Radiological

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510(K) Number K991282
Device Name Camera, Multi Format, Radiological
Applicant SEIKO INSTRUMENTS USA, INC.
2001 EAST OAKSHORES DR.
CROSSROADS, TX 76227 US
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Contact HERMAN OOSTERWJICK
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Regulation Number 892.2040

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Classification Product Code LMC
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Date Received 04/14/1999
Decision Date 06/30/1999
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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