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FDA 510(k) Application Details - K031660
Device Classification Name
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
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510(K) Number
K031660
Device Name
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)
Applicant
FERRIS MFG. CORP.
16W300 83RD ST.
BURR RIDGE, IL 60527-5848 US
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Contact
THEODORE R THORSEN
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Regulation Number
880.5630
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Classification Product Code
NTX
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More FDA Info for this Product Code
Date Received
05/28/2003
Decision Date
02/22/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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