FDA 510(k) Application Details - K980289

Device Classification Name Densitometer, Bone

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510(K) Number K980289
Device Name Densitometer, Bone
Applicant NORLAND CORP.
WEST 6340 HACKBARTH RD.
FORT ATKINSON, WI 53538-8999 US
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Contact TERRY SCHWALENBERG
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Regulation Number 892.1170

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Classification Product Code KGI
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Date Received 01/26/1998
Decision Date 06/12/1998
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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