FDA 510(k) Application Details - K971760

Device Classification Name Camera, Multi Format, Radiological

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510(K) Number K971760
Device Name Camera, Multi Format, Radiological
Applicant SEIKO INSTRUMENTS USA, INC.
1-8 NAKASE,MIHAMA-KU,CHIBA-SHI
CHIBA-KEN 271 JP
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Contact TOMOHIKO SAKAI
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Regulation Number 892.2040

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Classification Product Code LMC
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Date Received 05/12/1997
Decision Date 10/01/1997
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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