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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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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