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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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More FDA Info for this Product Code
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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