FDA 510(k) Application Details - K010677

Device Classification Name Arthroscope

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510(K) Number K010677
Device Name Arthroscope
Applicant MEDTRONIC XOMED, INC.
6743 SOUTHPOINT DR. NORTH
JACKSONVILLE, FL 32216 US
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Contact MARTIN D SARGENT
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 03/07/2001
Decision Date 05/07/2001
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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