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FDA 510(k), K983985, HYBRISONIC SHEATH
FDA 510(k), K983985, HYBRISONIC SHEATH
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510(K) Number: K983985
Device Name: HYBRISONIC SHEATH
Manufacturer: MARGARET J LARSON
Device Classification Name: Transducer, Ultrasonic, Diagnostic
Regulation Number: ITX
Classification Product Code: KXA
Date Received: 11/09/1998
Decision Date: 02/25/1999
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: HYBRISONIC SHEATH
Manufacturer: MARGARET J LARSON
Device Classification Name: Transducer, Ultrasonic, Diagnostic
Regulation Number: ITX
Classification Product Code: KXA
Date Received: 11/09/1998
Decision Date: 02/25/1999
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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