FDA 510(k) Application Details - K132747

Device Classification Name Light, Surgical, Ceiling Mounted

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510(K) Number K132747
Device Name Light, Surgical, Ceiling Mounted
Applicant STRYKER COMMUNICATIONS
1410 LAKESIDE PKWY., #100
FLOWER MOUND, TX 75028 US
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Contact TREY THORSEN
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Regulation Number 878.4580

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Classification Product Code FSY
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Date Received 09/03/2013
Decision Date 12/30/2013
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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