Bowel Management Device, Bowel Management Irrigation Set

Tubes, Gastrointestinal (and Accessories)

Applied Medical Technology, Inc.

The following data is part of a premarket notification filed by Applied Medical Technology, Inc. with the FDA for Bowel Management Device, Bowel Management Irrigation Set.

Pre-market Notification Details

• Device ID: K180026
• 510k Number: K180026
• Device Name: Bowel Management Device, Bowel Management Irrigation Set
• Classification: Tubes, Gastrointestinal (and Accessories)
• Applicant: Applied Medical Technology, Inc. 8006 Katherine Boulevard Brecksville, OH 44141
• Contact: Michelle Scott
• Correspondent: Joshua Meinke; Applied Medical Technology, Inc. 8006 Katherine Boulevard Brecksville, OH 44141
• Product Code: KNT
• CFR Regulation Number: 876.5980 [🔎]
• Decision: Substantially Equivalent - Kit (SESK)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-01-03
• Decision Date: 2018-06-01
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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