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FDA 510(k) Application Details - K983092
Device Classification Name
Motor, Drill, Pneumatic
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510(K) Number
K983092
Device Name
Motor, Drill, Pneumatic
Applicant
MEDNEXT, INC.
5490 DEXTER WAY
WEST PALM BEACH, FL 33407 US
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Contact
STEWART WILLASON
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Regulation Number
882.4370
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Classification Product Code
HBB
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More FDA Info for this Product Code
Date Received
09/03/1998
Decision Date
11/06/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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