FDA 510(k) Application Details - K110715

Device Classification Name Fiber, Medical, Absorbent

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510(K) Number K110715
Device Name Fiber, Medical, Absorbent
Applicant MILLIKEN HEALTHCARE PRODUCTS, LLC
920 MILLIKEN ROAD
SPARTANBURG, SC 29303 US
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Contact BRIAN J LINDSAY
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Regulation Number 880.5300

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Classification Product Code FRL
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Date Received 03/15/2011
Decision Date 11/04/2011
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

FDA Source Information for K110715


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