FDA 510(k) Application Details - K980137

Device Classification Name General Surgery Tray

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510(K) Number K980137
Device Name General Surgery Tray
Applicant WORLDWIDE MEDICAL TECHNOLOGIES, LLC
125 MAIN ST., NORTH
WOODBURY, CT 06798-0505 US
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Contact GARY LAMOUREUX
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Regulation Number 878.4370

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Classification Product Code LRO
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Date Received 01/15/1998
Decision Date 01/30/1998
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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