FDA 510(k) Application Details - K961122

Device Classification Name Lamp, Surgical

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510(K) Number K961122
Device Name Lamp, Surgical
Applicant STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact DIANE DAVIS
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Regulation Number 878.4580

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Classification Product Code FTD
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Date Received 03/21/1996
Decision Date 08/22/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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