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FDA 510(k) Application Details - K010179
Device Classification Name
Arthroscope
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510(K) Number
K010179
Device Name
Arthroscope
Applicant
EBI, L.P.
399 JEFFERSON ROAD
PARSIPPANY, NJ 07054 US
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Contact
JON CAPAROTTA
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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
01/19/2001
Decision Date
02/09/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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