FDA 510(k) Application Details - K053173

Device Classification Name Cassette, Radiographic Film

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510(K) Number K053173
Device Name Cassette, Radiographic Film
Applicant KONICA MINOLTA MEDICAL & GRAPHIC, INC.
319 AKENO, OBATA-CHO
WATARAI-GUN
MIE-KEN 519-05 JP
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Contact SHINICHI YAMANAKA
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Regulation Number 892.1850

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Classification Product Code IXA
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Date Received 11/14/2005
Decision Date 12/15/2005
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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