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FDA 510(k) Application Details - K070078

Device Classification Name Gown, Surgical

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510(K) Number K070078
Device Name Gown, Surgical
Applicant STRYKER INSTRUMENTS, INSTRUMENTS DIV.
4100 EAST MILHAM AVE.
KALAMAZOO, MI US
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Contact PAULETTE D JOHNSON
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Regulation Number 878.4040

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Classification Product Code FYA
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Date Received 01/09/2007
Decision Date 02/02/2007
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review N



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