Bite Away

Pad, Heating, Powered

Riemser Pharma

The following data is part of a premarket notification filed by Riemser Pharma with the FDA for Bite Away.

Pre-market Notification Details

• Device ID: K160943
• 510k Number: K160943
• Device Name: Bite Away
• Classification: Pad, Heating, Powered
• Applicant: Riemser Pharma An Der Wiek 7 Greifswald-insel Riems, DE D-17493
• Contact: Ronny Raasch
• Correspondent: Kenneth K. Kleinhenz; Quality Systems Resources (QSR) 10807 Dakota Ranch Rd. Santee, CA 92071
• Product Code: IRT
• CFR Regulation Number: 890.5740 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-05
• Decision Date: 2016-08-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04260624040295	K160943	000