FDA 510(k) Application Details - K955706

Device Classification Name Processor, Radiographic-Film, Automatic

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510(K) Number K955706
Device Name Processor, Radiographic-Film, Automatic
Applicant JPI HEALTHCARE CO., LTD
41-02 BELL BLVD.
SUITE LL3
BAYSIDE, NY 11361 US
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Contact KIM M LEE
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Regulation Number 892.1900

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Classification Product Code IXW
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Date Received 12/15/1995
Decision Date 02/12/1996
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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