FDA 510(k) Application Details - K973712

Device Classification Name System, X-Ray, Mobile

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510(K) Number K973712
Device Name System, X-Ray, Mobile
Applicant MINXRAY, INC.
3611 COMMERCIAL AVE.
NORTHBROOK, IL 60062 US
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Contact KEITH R KRETCHMER
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Regulation Number 892.1720

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Classification Product Code IZL
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Date Received 09/29/1997
Decision Date 12/12/1997
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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