FDA 510(k) Application Details - K113028

Device Classification Name Arthroscope

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510(K) Number K113028
Device Name Arthroscope
Applicant MEDISISS
2747 SW 6TH STREET
REDMOND, OR 97756 US
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Contact JOYCE ELKINS
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Regulation Number 888.1100

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Classification Product Code HRX
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Date Received 10/11/2011
Decision Date 12/20/2011
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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