FDA 510(k) Application Details - K965201

Device Classification Name General Surgery Tray

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510(K) Number K965201
Device Name General Surgery Tray
Applicant TRINITY LABORATORIES, INC.
201 KILEY DR.
SALISBURY, MD 21801 US
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Contact PARTHA BASUMALLIK
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Regulation Number 878.4370

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Classification Product Code LRO
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Date Received 12/26/1996
Decision Date 02/14/1997
Decision SEKD - SUBST EQUIV - KIT WITH DRUGS
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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