FDA 510(k) Application Details - K080367

Device Classification Name Light, Surgical, Fiberoptic

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510(K) Number K080367
Device Name Light, Surgical, Fiberoptic
Applicant ZIMMER SPINE, INC.
7375 BUSH LAKE RD.
MINNEAPOLIS, MN 55439 US
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Contact ELSA A LINKE
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Regulation Number 878.4580

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Classification Product Code FST
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Date Received 02/12/2008
Decision Date 02/22/2008
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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