FDA 510(k) Application Details - K061615

Device Classification Name Fiber, Medical, Absorbent

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510(K) Number K061615
Device Name Fiber, Medical, Absorbent
Applicant MILLIKEN CHEMICAL
49 PLAIN STREET
NORTH ATTLEBORO, MA 02760 US
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Contact MARY MCNAMARA-CULLINANE
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Regulation Number 880.5300

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Classification Product Code FRL
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Date Received 06/09/2006
Decision Date 12/22/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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