FDA 510(k) Application Details - K130057

Device Classification Name Arthroscope

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510(K) Number K130057
Device Name Arthroscope
Applicant NLT SPINE LTD
555 THIRTEENTH STREET NW
WASHINGTON, DC 20004 US
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Contact JOHN J SMITH
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 01/09/2013
Decision Date 02/07/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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