FDA 510(k) Application Details - K981717

Device Classification Name Lamp, Surgical

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510(K) Number K981717
Device Name Lamp, Surgical
Applicant STRYKER INSTRUMENTS
4100 EAST MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact NICOLE PETTY
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Regulation Number 878.4580

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Classification Product Code FTD
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Date Received 05/15/1998
Decision Date 06/30/1998
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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