FDA 510(k) Application Details - K030196

Device Classification Name Arthroscope

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510(K) Number K030196
Device Name Arthroscope
Applicant SMITH & NEPHEW, INC.
150 MINUTEMAN RD.
ANDOVER, MA 01810 US
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Contact JANICE HASELTON
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 01/21/2003
Decision Date 02/20/2003
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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