AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE

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 Amt Button Replacement Gastrostomy Device.

Pre-market Notification Details

• Device ID: K980305
• 510k Number: K980305
• Device Name: AMT BUTTON REPLACEMENT GASTROSTOMY DEVICE
• Classification: Tubes, Gastrointestinal (and Accessories)
• Applicant: APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland, OH 44128
• Contact: Thomas W Parkinson
• Correspondent: Thomas W Parkinson; APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland, OH 44128
• Product Code: KNT
• CFR Regulation Number: 876.5980 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-01-27
• Decision Date: 1998-04-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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