FDA 510(k) Application Details - K002523

Device Classification Name Motor, Drill, Electric

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510(K) Number K002523
Device Name Motor, Drill, Electric
Applicant LINVATEC CORP.
11311 CONCEPT BLVD.
LARGO, FL 33773-4908 US
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Contact LAURA D SENEFF
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Regulation Number 882.4360

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Classification Product Code HBC
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Date Received 08/15/2000
Decision Date 10/06/2000
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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