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U.S. Department of Health and Human Services

Import Refusal Report

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Refusal Details as Recorded in OASIS by FDA

for Refusal AM1-0115089-5/1/1


Manufacturer FEI3002806988
Manufacturer NameFisher & Paykel Healthcare, Ltd.  
Manufacturer Address line 115 Maurice Paykel Place  
Manufacturer Address line 2East Tamaki  
Manufacturer's CityAuckland  
Manufacturer Province/State  
Manufacturer Country/AreaNew Zealand  
Product Code79FXX  
Importer's Product DescriptionMEDICAL ACCESORIES (NASAL MASK)]]]]]]FOR EXPORT ONLY]]]]]]]]]]]]]  
Refusal Date10-Jan-2005  
FDA DistrictFLA-DO  
Entry/doc/line/sfx AM1-0115089-5/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NO 510(K)   801(a)(3); 502(o) Misbranding   It appears that a notice or other information respecting the device was not provided to FDA, as required by Section 510(k) and the device was not found to be substantially equivalent to a predicate device.  
NOT LISTED   502(o), 801(a)(3); MISBRANDING   It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).  
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