FDA 510(k) Application Details - K991625

Device Classification Name Motor, Drill, Pneumatic

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510(K) Number K991625
Device Name Motor, Drill, Pneumatic
Applicant KOMET MEDICAL
2188 KNOLL DR.
SAVANNAH, GA 31419 US
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Contact COURTNEY S PARADICE
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Regulation Number 882.4370

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Classification Product Code HBB
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Date Received 05/11/1999
Decision Date 07/30/1999
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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