FDA 510(k) Application Details - K965226

Device Classification Name System, Tomography, Computed, Emission

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510(K) Number K965226
Device Name System, Tomography, Computed, Emission
Applicant LUNAR CORP.
313 WEST BELTLINE HIGHWAY
MADISON, WI 53713 US
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Contact KENNETH D BUROKER
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Regulation Number 892.1200

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Classification Product Code KPS
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Date Received 12/30/1996
Decision Date 10/03/1997
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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