FDA 510(k) Application Details - K051625

Device Classification Name Drape, Surgical

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510(K) Number K051625
Device Name Drape, Surgical
Applicant MOLNLYCKE HEALTH CARE, INC.
826 NEWTOWN-YARDLEY RD.
NEWTOWN, PA 18940 US
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Contact JOHN CLAY
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Regulation Number 878.4370

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Classification Product Code KKX
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Date Received 06/20/2005
Decision Date 07/14/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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