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FDA 510(k), K954798, 7100 SWALLOWING WORKSTATION
FDA 510(k), K954798, 7100 SWALLOWING WORKSTATION
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510(K) Number: K954798
Device Name: 7100 SWALLOWING WORKSTATION
Manufacturer: KAY ELEMETRICS CORP.
Device Classification Name: monitor, esophageal motility, anorectal motility, and tube
Regulation Number: 876.1725
Classification Product Code: KLA
Date Received: 10/18/1995
Decision Date: 06/04/1996
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: 7100 SWALLOWING WORKSTATION
Manufacturer: KAY ELEMETRICS CORP.
Device Classification Name: monitor, esophageal motility, anorectal motility, and tube
Regulation Number: 876.1725
Classification Product Code: KLA
Date Received: 10/18/1995
Decision Date: 06/04/1996
Regulation Medical Specialty: Gastroenterology/Urology
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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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