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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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More FDA Info for this Product Code
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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