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FDA 510(k) Application Details - K041978
Device Classification Name
Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
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510(K) Number
K041978
Device Name
Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed
Applicant
ALLIANCE MEDICAL CORP.
10232 SOUTH 51ST ST.
PHOENIX, AZ 85044 US
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Contact
ERIC VARTY
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Regulation Number
882.4310
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Classification Product Code
NLN
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More FDA Info for this Product Code
Date Received
07/23/2004
Decision Date
11/23/2004
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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