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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 112-6285039-3/1/1


Manufacturer FEI3008182617
Manufacturer NameDanamedic Aps  
Manufacturer Address line 1Maglebjergvej 4  
Manufacturer Address line 2  
Manufacturer's CityKongens Lyngby  
Manufacturer Province/State  
Manufacturer Country/AreaDenmark  
Product Code78NHU  
FDA Product DescriptionEXTENDER, PENILE, MECHANICAL  
Refusal Date15-Mar-2011  
FDA DistrictNOL-DO  
Entry/doc/line/sfx 112-6285039-3/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
Violation Code Section Charge Statement
NO PMA   501(f)(1)(B), 801(a)(3); ADULTERATION   The article appears to be a class III device without an approved application for premarket approval pursuant to section 515(a).  
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