FDA 510(k) Application Details - K090815

Device Classification Name Arthroscope

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510(K) Number K090815
Device Name Arthroscope
Applicant LAURIMED LLC
500 ARGUELLO STREET, SUITE 100
REDWOOD CITY, CA 94063 US
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Contact SEVRINA CIUCCI
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 03/25/2009
Decision Date 05/21/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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