NEUTRASAL

Saliva, Artificial

BARTOR PHARMACAL CO., INC.

The following data is part of a premarket notification filed by Bartor Pharmacal Co., Inc. with the FDA for Neutrasal.

Pre-market Notification Details

• Device ID: K091718
• 510k Number: K091718
• Device Name: NEUTRASAL
• Classification: Saliva, Artificial
• Applicant: BARTOR PHARMACAL CO., INC. 25 RAVENNA DRIVE Pomona, NY 10970
• Contact: Edward D Kobus
• Correspondent: Edward D Kobus; BARTOR PHARMACAL CO., INC. 25 RAVENNA DRIVE Pomona, NY 10970
• 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: 2009-06-11
• Decision Date: 2009-09-02
• Summary: summary