Refusal Actions by FDA as Recorded in OASIS



    Manufacturer FEI: 3004617194
    Manufacturer Name: Gwg Ges. Wasser & Gesundheit Mbh
    Manufacturer address line 1: Postfach 30
    Manufacturer address line 2:
    Manufacturer City: Friesenheim
    Manufacturer Province/state:
    Manufacturer Country: Germany
    Product code: 73B--WK
    Importers product description: 706862723810/ACUPUNCTURE SET
    Refusal date: 17-MAR-2008
    FDA_District: NOL-DO
    Entry/doc/line/sfx: 112-1721307-6/1/1/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED


    Manufacturer FEI: 3005990926
    Manufacturer Name: Guangzhou Jinyimei
    Manufacturer address line 1: 64 Heugqigang Rd
    Manufacturer address line 2:
    Manufacturer City: Guangzhou
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 73B--YG
    Importers product description: OXYGEN MASK
    Refusal date: 03-MAR-2008
    FDA_District: SWI-DO
    Entry/doc/line/sfx: ARJ-0006856-8/1/3/
    Carrier: WAN HAI LINES LTD
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED


    Manufacturer FEI: 3005990926
    Manufacturer Name: Guangzhou Jinyimei
    Manufacturer address line 1: 64 Heugqigang Rd
    Manufacturer address line 2:
    Manufacturer City: Guangzhou
    Manufacturer Province/state:
    Manufacturer Country: China
    Product code: 73C--AW
    Importers product description: HOME OXYGEN BAR
    Refusal date: 03-MAR-2008
    FDA_District: SWI-DO
    Entry/doc/line/sfx: ARJ-0006856-8/1/4/
    Carrier: WAN HAI LINES LTD
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED


    Manufacturer FEI: 3006056594
    Manufacturer Name: Charmcare Co. Ltd
    Manufacturer address line 1: 918ho Woolim Lions 2-Cha Gasan-Dong,
    Manufacturer address line 2:
    Manufacturer City: Seoul
    Manufacturer Province/state:
    Manufacturer Country: Korea, Republic Of (South)
    Product code: 73D--QA
    Importers product description: 8597-1745-0585 Pulse Oximeters - w/o veterinary-use-only lab
    Refusal date: 13-MAR-2008
    FDA_District: SEA-DO
    Entry/doc/line/sfx: 112-1683254-6/1/1/
    Carrier: FEDERAL EXPRESS
    Bill of Lading:
    FDA sample analysis: No
    FDA record of private lab sample analysis: No
    Charge(s): NOT LISTED
               NO 510(K)