FDA 510(k) Application Details - K961007

Device Classification Name Densitometer, Bone

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510(K) Number K961007
Device Name Densitometer, Bone
Applicant LUNAR CORP.
313 WEST BELTLINE HIGHWAY
MADISON, WI 53713 US
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Contact Gary Syring
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Regulation Number 892.1170

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Classification Product Code KGI
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Date Received 03/12/1996
Decision Date 07/25/1996
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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