FDA 510(k) Application Details - K021331

Device Classification Name Densitometer, Bone

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510(K) Number K021331
Device Name Densitometer, Bone
Applicant OSTEOMETER MEDITECH, INC.
12515 CHADRON AVE.
HAWTHORNE, CA 90250 US
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Contact RAJA KRISHNAMURTI
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Regulation Number 892.1170

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Classification Product Code KGI
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Date Received 04/26/2002
Decision Date 05/21/2002
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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