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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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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