FDA 510(k) Application Details - K001429

Device Classification Name Densitometer, Bone

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510(K) Number K001429
Device Name Densitometer, Bone
Applicant SCHICK TECHNOLOGIES, INC.
31-00 47TH AVE.
LONG ISLAND, NY 11101 US
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Contact DANIEL MICHAELI
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Regulation Number 892.1170

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Classification Product Code KGI
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Date Received 05/05/2000
Decision Date 05/26/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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