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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 112-3685667-5/1/1

Manufacturer FEI3008110918
Manufacturer NameMdk Sha Medical Packing Co Ltd  
Manufacturer Address line 1233 Fengjian Rd Touqiaoeconomic  
Manufacturer Address line 2  
Manufacturer's CitySh¿nghaish¿  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code80FRG  
FDA Product DescriptionWRAP, STERILIZATION  
Refusal Date16-Nov-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-3685667-5/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).