FDA 510(k) Application Details - K020083

Device Classification Name Arthroscope

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510(K) Number K020083
Device Name Arthroscope
Applicant TUTA HEALTHCARE PTY LIMITED
318-332 BURNS BAY ROAD
LANE COVE
SYDNEY NSW 2066 AU
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Contact OMID SOURESRAFIL
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 01/10/2002
Decision Date 02/12/2002
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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