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FDA 510(k) Application Details - K051291

Device Classification Name Mask, Surgical

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510(K) Number K051291
Device Name Mask, Surgical
Applicant A.R. MEDICOM, INC.
1200 55TH AVE.
LACHINE, QUEBEC H8T 3J8 CA
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Contact LUC TREPANIER
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Regulation Number 878.4040

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Classification Product Code FXX
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Date Received 05/18/2005
Decision Date 09/20/2005
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review N



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