FDA 510(k) Application Details - K983273

Device Classification Name Densitometer, Bone

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510(K) Number K983273
Device Name Densitometer, Bone
Applicant MEDICAL SYSTEMS, INC.
W6340 HACKBARTH RD.
FORT ATKINSON, WI 53538 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 09/17/1998
Decision Date 10/29/1998
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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