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)