FDA 510(k) Application Details - K080122

Device Classification Name Arthroscope

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510(K) Number K080122
Device Name Arthroscope
Applicant SOPRO
124 GAITHER DRIVE
SUITE 140
MT. LAUREL, NJ 08054 US
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Contact STEVE SALESKY
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 01/17/2008
Decision Date 07/11/2008
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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