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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 009-1584915-2/1/1

Manufacturer FEI3004983316
Manufacturer NamePharma Mar SA  
Manufacturer Address line 1Pol. Ind. La Mina  
Manufacturer Address line 2Avenida de los Reyes 1  
Manufacturer's CityColmenar Viejo  
Manufacturer Province/StateMadrid  
Manufacturer Country/AreaSpain  
Product Code80FMF  
FDA Product DescriptionSYRINGE, PISTON  
Refusal Date14-Dec-2005  
FDA DistrictCHI-DO  
Entry/doc/line/sfx 009-1584915-2/1/1
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).  
REGISTERED   502(o), 801(a)(3); MISBRANDING   It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).