MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20

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 Monarch, Transshaping Gastrostomy Tube, Model 9-xx20.

Pre-market Notification Details

• Device ID: K043027
• 510k Number: K043027
• Device Name: MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20
• Classification: Tubes, Gastrointestinal (and Accessories)
• Applicant: APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland, OH 44128
• Contact: Derek Williams
• Correspondent: Derek Williams; APPLIED MEDICAL TECHNOLOGY, INC. 15653 NEO PKWY. Cleveland, OH 44128
• Product Code: KNT
• CFR Regulation Number: 876.5980 [🔎]
• Decision: Substantially Equivalent - Kit (SESK)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-11-03
• Decision Date: 2004-12-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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