FDA 510(k) Application Details - K013481

Device Classification Name System, X-Ray, Stationary

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510(K) Number K013481
Device Name System, X-Ray, Stationary
Applicant GE MEDICAL SYSTEMS
3000 N. GRANDVIEW BLVD.
WAUKESHA, WI 53188 US
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Contact JODI PARKER
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Regulation Number 892.1680

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Classification Product Code KPR
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Date Received 10/19/2001
Decision Date 11/02/2001
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 Y
Expedited Review



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