FDA 510(k) Application Details - K974579

Device Classification Name Arthroscope

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510(K) Number K974579
Device Name Arthroscope
Applicant CLARUS MEDICAL SYSTEMS, INC.
1000 BOONE AVENUE NORTH
#100
MINNEAPOLIS, MN 55427-8656 US
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Contact DALE SAPPENFIELD
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 12/08/1997
Decision Date 02/18/1998
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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