SmartMouth DryMouth Oral Rinse

Saliva, Artificial

Triumph Pharmaceuticals, Inc.

The following data is part of a premarket notification filed by Triumph Pharmaceuticals, Inc. with the FDA for Smartmouth Drymouth Oral Rinse.

Pre-market Notification Details

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• Device ID: K181194
• 510k Number: K181194
• Device Name: SmartMouth DryMouth Oral Rinse
• Classification: Saliva, Artificial
• Applicant: Triumph Pharmaceuticals, Inc. 12312 Olive Blvd., Ste. 250 St. Louis, MO 63141
• Contact: Andrew Burch
• Correspondent: H. Carl Jenkins; Wood Burditt Group 10 E. Scranton Ave., Ste. 201 Lake Bluff, IL 60044
• Product Code: LFD
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-05-04
• Decision Date: 2019-02-15
• Summary: summary