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FDA 510(k) Application Details - K961787
Device Classification Name
Densitometer, Bone
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510(K) Number
K961787
Device Name
Densitometer, Bone
Applicant
HOLOGIC, INC.
1700 ROCKVILLE PIKE
SUITE 450
ROCKVILLE, MD 20852 US
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Contact
R. MICHAEL CROMPTON
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Regulation Number
892.1170
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Classification Product Code
KGI
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More FDA Info for this Product Code
Date Received
05/09/1996
Decision Date
06/13/1997
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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