FDA 510(k) Application Details - K953913

Device Classification Name Arthroscope

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510(K) Number K953913
Device Name Arthroscope
Applicant OPTUS, INC.
1200 SOUTH PARKER RD.
DENVER, CO 80231 US
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Contact PETER DUFFY
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 08/21/1995
Decision Date 01/22/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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