Hydris™ Oral Rinse

Saliva, Artificial

BIOPHARM CONSULT, L.L.C.

The following data is part of a premarket notification filed by Biopharm Consult, L.l.c. with the FDA for Hydris™ Oral Rinse.

Pre-market Notification Details

• Device ID: K163029
• 510k Number: K163029
• Device Name: Hydris™ Oral Rinse
• Classification: Saliva, Artificial
• Applicant: BIOPHARM CONSULT, L.L.C. 5609 HARD ROCK PLACE Henrico, VA 23230
• Contact: David S. Johnson
• Correspondent: David S. Johnson; BIOPHARM CONSULT, L.L.C. 5609 HARD ROCK PLACE Henrico, VA 23230
• Product Code: LFD
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-10-31
• Decision Date: 2017-06-19
• Summary: summary