VeriSplint

Mouthguard, Prescription

Whip Mix Corporation

The following data is part of a premarket notification filed by Whip Mix Corporation with the FDA for Verisplint.

Pre-market Notification Details

• Device ID: K190107
• 510k Number: K190107
• Device Name: VeriSplint
• Classification: Mouthguard, Prescription
• Applicant: Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217
• Contact: John Waters
• Correspondent: John Waters; Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217
• Product Code: MQC
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-01-22
• Decision Date: 2019-07-10

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D040711471	K190107	000
D040711740	K190107	000