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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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PETER DUFFY
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Regulation Number
888.1100
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Classification Product Code
HRX
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More FDA Info for this Product Code
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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