FDA 510(k) Application Details - K050580

Device Classification Name Arthroscope

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510(K) Number K050580
Device Name Arthroscope
Applicant SMITH & NEPHEW ENDOSCOPY, INC.
150 Minuteman Road
Andover, MA 01810 US
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Contact KATHLEEN BURNS
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 03/07/2005
Decision Date 04/20/2005
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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