FDA 510(k) Application Details - K955914

Device Classification Name Arthroscope

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510(K) Number K955914
Device Name Arthroscope
Applicant SMITH & NEPHEW DYONICS, INC.
160 DASCOMB RD.
ANDOVER, MA 01810 US
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Contact ELIZABETH A RYAN
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 12/15/1995
Decision Date 02/08/1996
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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