FDA 510(k) Application Details - K002008

Device Classification Name Arthroscope

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510(K) Number K002008
Device Name Arthroscope
Applicant UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
150 GLOVER AVE.
NORWALK, CT 06856 US
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Contact JENNIFER E SCHUCK
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 07/03/2000
Decision Date 08/16/2000
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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