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FDA 510(k), K970513, GENERAL PURPOSE TRANDUCER COVER
FDA 510(k), K970513, GENERAL PURPOSE TRANDUCER COVER
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510(K) Number: K970513
Device Name: GENERAL PURPOSE TRANDUCER COVER
Manufacturer: J. WILLIAM JONES
Device Classification Name: Transducer, Ultrasonic, Diagnostic
Regulation Number: ITX
Classification Product Code: KXA
Date Received: 02/11/1997
Decision Date: 06/20/1997
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: GENERAL PURPOSE TRANDUCER COVER
Manufacturer: J. WILLIAM JONES
Device Classification Name: Transducer, Ultrasonic, Diagnostic
Regulation Number: ITX
Classification Product Code: KXA
Date Received: 02/11/1997
Decision Date: 06/20/1997
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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