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FDA 510(k), K051799, DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
FDA 510(k), K051799, DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
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510(K) Number: K051799
Device Name: DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
Manufacturer: COEUR, INC.
Device Classification Name: injector and syringe, angiographic
Regulation Number: 870.1650
Classification Product Code: DXT
Date Received: 07/05/2005
Decision Date: 11/02/2005
Regulation Medical Specialty: Cardiovascular
Device Name: DISPOSABLE CT/MR SYRINGES FOR NEMOTO INJECTORS
Manufacturer: COEUR, INC.
Device Classification Name: injector and syringe, angiographic
Regulation Number: 870.1650
Classification Product Code: DXT
Date Received: 07/05/2005
Decision Date: 11/02/2005
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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