FDA 510(k) Application Details - K002755

Device Classification Name Wire, Surgical

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510(K) Number K002755
Device Name Wire, Surgical
Applicant T. KOROS SURGICAL INSTRUMENTS CORP.
610 FLINN AVE.
MOORPARK, CA 93021 US
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Contact TIBOR KOROS
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Regulation Number 000.0000

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Classification Product Code LRN
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Date Received 09/05/2000
Decision Date 12/04/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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