FDA 510(k) Application Details - K993750

Device Classification Name System, Image Processing, Radiological

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510(K) Number K993750
Device Name System, Image Processing, Radiological
Applicant PROBLEM SOLVING CONCEPTS, INC.
1980 E. 116TH ST.
SUITE 220
CARMEL, IN 46032 US
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Contact THOMAS M MCCLELLAND
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Regulation Number 892.2050

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Classification Product Code LLZ
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Date Received 11/05/1999
Decision Date 02/02/2000
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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