FDA 510(k) Application Details - K041135

Device Classification Name Arthroscope

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510(K) Number K041135
Device Name Arthroscope
Applicant DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
249 VANDERBILT AVE.
NORWOOD, MA 02062 US
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Contact RUTH C FORSTADT
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 04/30/2004
Decision Date 05/10/2004
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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