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FDA 510(k) Application Details - K961011
Device Classification Name
Densitometer, Bone
More FDA Info for this Device
510(K) Number
K961011
Device Name
Densitometer, Bone
Applicant
SHOTWELL & CARR, INC.
3003 LBJ FREEWAY, SUITE 100
DALLAS, TX 75234-7755 US
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Contact
BERT HUDSON
Other 510(k) Applications for this Contact
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
03/13/1996
Decision Date
07/05/1996
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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