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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 225-5135889-2/1/1

Manufacturer FEI3003726049
Manufacturer NameJohn Moncrieff Limited  
Manufacturer Address line 1Unit 1 9 Frederick Crescent  
Manufacturer Address line 2  
Manufacturer's CityScotland  
Manufacturer Province/State  
Manufacturer Country/AreaUnited Kingdom  
Product Code85HII  
Importer's Product DescriptionKAGLE MUSCLE EXERCISER MADE OF GLASS  
Refusal Date21-Aug-2002  
FDA DistrictFLA-DO  
Entry/doc/line/sfx 225-5135889-2/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
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).