FDA 510(k) Application Details - K082781

Device Classification Name

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510(K) Number K082781
Device Name OEC 9900 ELITE
Applicant GE HEALTHCARE SURGERY
384 WRIGHT BROTHERS DRIVE
SALT LAKE CITY, UT 84116 US
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Contact MARIA C FRAME
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Regulation Number

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Classification Product Code OWB
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Date Received 09/22/2008
Decision Date 05/01/2009
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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