FDA 510(k) Application Details - K032473

Device Classification Name Arthroscope

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510(K) Number K032473
Device Name Arthroscope
Applicant STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact ROBIN L ROWE
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 08/12/2003
Decision Date 11/07/2003
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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