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FDA 510(k) Application Details - K983273
Device Classification Name
Densitometer, Bone
More FDA Info for this Device
510(K) Number
K983273
Device Name
Densitometer, Bone
Applicant
MEDICAL SYSTEMS, INC.
W6340 HACKBARTH RD.
FORT ATKINSON, WI 53538 US
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Contact
TERRY SCHWALENBERG
Other 510(k) Applications for this Contact
Regulation Number
892.1170
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Classification Product Code
KGI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/17/1998
Decision Date
10/29/1998
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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