• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Import Refusal Report

  • Print
  • Share
  • E-mail

Refusal Details as Recorded in OASIS by FDA

for Refusal 946-0630209-2/1/1

Manufacturer FEI3007013085
Manufacturer NameDelma Medical Instrument (Guangzhou) Co., Ltd.  
Manufacturer Address line 117 Th Ciang Shan Road.  
Manufacturer Address line 2  
Manufacturer's CityScientific City, Guangzhou, Guangdong  
Manufacturer Province/State  
Manufacturer Country/AreaChina  
Product Code76NRU  
Refusal Date04-Nov-2011  
FDA DistrictLOS-DO  
Entry/doc/line/sfx 946-0630209-2/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Violation Code Section Charge Statement
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).