FDA 510(k) Application Details - K981124

Device Classification Name Densitometer, Bone

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510(K) Number K981124
Device Name Densitometer, Bone
Applicant SCHICK TECHNOLOGIES, INC.
12300 TWINBROOK PARKWAY,
SUITE 625
ROCKVILLE, MD 20852 US
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Contact T. WHIT ATHEY
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Regulation Number 892.1170

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Classification Product Code KGI
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Date Received 03/27/1998
Decision Date 06/04/1998
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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