FDA 510(k) Application Details - K092723

Device Classification Name Arthroscope

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510(K) Number K092723
Device Name Arthroscope
Applicant SKELETAL DYNAMICS, LLC
80 SHELDON TECHNOLOGY CENTER
SHELTON, CT 06484 US
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Contact JOSEPH M AZARY
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 09/04/2009
Decision Date 10/04/2010
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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