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FDA 510(k) Application Details - K000162
Device Classification Name
Densitometer, Bone
More FDA Info for this Device
510(K) Number
K000162
Device Name
Densitometer, Bone
Applicant
ALARA, INC.
2545 BARRINGTON CT.
HAYWARD, CA 94545-1134 US
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Contact
DIANE M KING
Other 510(k) Applications for this Contact
Regulation Number
892.1170
More FDA Info for this Regulation Number
Classification Product Code
KGI
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More FDA Info for this Product Code
Date Received
01/19/2000
Decision Date
05/12/2000
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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