FDA 510(k) Application Details - K122637

Device Classification Name Light, Surgical, Fiberoptic

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510(K) Number K122637
Device Name Light, Surgical, Fiberoptic
Applicant STRYKER SPINE
2 PEARL COURT
ALLENDALE, NJ 07401 US
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Contact TINA MORNAK
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Regulation Number 878.4580

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Classification Product Code FST
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Date Received 08/29/2012
Decision Date 11/01/2012
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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