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FDA 510(k) Application Details - K972857
Device Classification Name
Motor, Drill, Electric
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510(K) Number
K972857
Device Name
Motor, Drill, Electric
Applicant
MEDICON, E.G.
555 THIRTEENTH STREET, N.W.
WASHINGTON, DC 20004-1109 US
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Contact
HOWARD M HOLSTEIN
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Regulation Number
882.4360
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Classification Product Code
HBC
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More FDA Info for this Product Code
Date Received
08/01/1997
Decision Date
01/16/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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