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FDA 510(k) Application Details - K001951

Device Classification Name Mask, Surgical

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510(K) Number K001951
Device Name Mask, Surgical
Applicant PRIMELINE MEDICAL PRODUCTS, INC.
10707 100TH AVE., SUITE 300
EDMONTON, ALBERTA T5J 3M1 CA
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Contact KATHERINE CO
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Regulation Number 878.4040

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Classification Product Code FXX
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Date Received 06/27/2000
Decision Date 09/08/2000
Decision SE - Substantially Equivalent
Classification Advisory Committee HO - General Hospital
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review N



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