FDA 510(k) Application Details - K982267

Device Classification Name Densitometer, Bone

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510(K) Number K982267
Device Name Densitometer, Bone
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 892.1170

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Classification Product Code KGI
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Date Received 06/29/1998
Decision Date 08/18/1998
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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