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FDA 510(k), K101952, KONIX ULTRASOUND GEL
FDA 510(k), K101952, KONIX ULTRASOUND GEL
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510(K) Number: K101952
Device Name: KONIX ULTRASOUND GEL
Manufacturer: MICHAEL SCOTT
Device Classification Name: Transducer, Ultrasonic, Diagnostic
Regulation Number: ITX
Classification Product Code: KXA
Date Received: 07/12/2010
Decision Date: 05/27/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: KONIX ULTRASOUND GEL
Manufacturer: MICHAEL SCOTT
Device Classification Name: Transducer, Ultrasonic, Diagnostic
Regulation Number: ITX
Classification Product Code: KXA
Date Received: 07/12/2010
Decision Date: 05/27/2011
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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