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FDA 510(k), K973844, GASTRIC AND RECTAL CATHETERS
FDA 510(k), K973844, GASTRIC AND RECTAL CATHETERS
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510(K) Number: K973844
Device Name: GASTRIC AND RECTAL CATHETERS
Manufacturer: SAM JUNDLER
Device Classification Name: System, Gastrointestinal Motility (Electrical)
Regulation Number: FFX
Classification Product Code: KXA
Date Received: 10/08/1997
Decision Date: 06/04/1999
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Gastroenterology/Urology
Device Name: GASTRIC AND RECTAL CATHETERS
Manufacturer: SAM JUNDLER
Device Classification Name: System, Gastrointestinal Motility (Electrical)
Regulation Number: FFX
Classification Product Code: KXA
Date Received: 10/08/1997
Decision Date: 06/04/1999
Decision: Substantially Equivalent (SESE)
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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