• 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 004-3974591-0/1/1


Manufacturer FEI3005171252
Manufacturer NameCbm Srl Officine Metalmeccaniche  
Manufacturer Address line 126038 Torre De Picenardi  
Manufacturer Address line 2  
Manufacturer's CityCremona  
Manufacturer Province/State  
Manufacturer Country/AreaItaly  
Product Code80LDQ  
FDA Product DescriptionDEVICE, GENERAL MEDICAL  
Refusal Date27-Dec-2005  
FDA DistrictFLA-DO  
Entry/doc/line/sfx 004-3974591-0/1/1
FDA Sample AnalysisNo  
FDA Record of Private Lab Sample Analysis No  
Charge(s)
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.  
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).  
-
-