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FDA 510(k) Application Details - K990813
Device Classification Name
Exerciser, Measuring
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510(K) Number
K990813
Device Name
Exerciser, Measuring
Applicant
ELECTROMED CORP.
PO 7007
DEERFIELD, IL 60015 US
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Contact
DANIEL KAMM
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Regulation Number
890.5360
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Classification Product Code
ISD
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More FDA Info for this Product Code
Date Received
03/11/1999
Decision Date
04/12/1999
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
PM - Physical Medicine
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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