FDA 510(k) Application Details - K012991

Device Classification Name Apparatus, Exhaust, Surgical

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510(K) Number K012991
Device Name Apparatus, Exhaust, Surgical
Applicant STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact SUZANNE VELAZQUEZ
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Regulation Number 878.5070

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Classification Product Code FYD
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Date Received 09/06/2001
Decision Date 11/29/2001
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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