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FDA 510(k), K091828, SHEATHESISO ULTRASOUND TRANSDUCER COVER
FDA 510(k), K091828, SHEATHESISO ULTRASOUND TRANSDUCER COVER
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510(K) Number: K091828
Device Name: SHEATHESISO ULTRASOUND TRANSDUCER COVER
Manufacturer: JENNIFER DOWNING
Device Classification Name: Transducer, Ultrasonic, Diagnostic
Regulation Number: ITX
Classification Product Code: KXA
Date Received: 06/19/2009
Decision Date: 09/28/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: SHEATHESISO ULTRASOUND TRANSDUCER COVER
Manufacturer: JENNIFER DOWNING
Device Classification Name: Transducer, Ultrasonic, Diagnostic
Regulation Number: ITX
Classification Product Code: KXA
Date Received: 06/19/2009
Decision Date: 09/28/2009
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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