FDA 510(k) Application Details - K981962

Device Classification Name Light, Surgical, Floor Standing

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510(K) Number K981962
Device Name Light, Surgical, Floor Standing
Applicant CUDA PRODUCTS CO.
6000 POWERS AVE.
JACKSONVILLE, FL 32217 US
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Contact JOSEPH CUDA
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Regulation Number 878.4580

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Classification Product Code FSS
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Date Received 06/04/1998
Decision Date 08/18/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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