PROCTIGARD

Protective Coating, Mucoadhesive Application, For The Rectal Mucosa

ACCESS PHARMACEUTICALS, INC

The following data is part of a premarket notification filed by Access Pharmaceuticals, Inc with the FDA for Proctigard.

Pre-market Notification Details

• Device ID: K140558
• 510k Number: K140558
• Device Name: PROCTIGARD
• Classification: Protective Coating, Mucoadhesive Application, For The Rectal Mucosa
• Applicant: ACCESS PHARMACEUTICALS, INC 1325 AVENUE OF THE AMERICA, 27TH FLOOR New York, NY 10019
• Contact: Jeffrey B Davis
• Correspondent: Jeffrey B Davis; ACCESS PHARMACEUTICALS, INC 1325 AVENUE OF THE AMERICA, 27TH FLOOR New York, NY 10019
• Product Code: PHN
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-03-05
• Decision Date: 2014-07-16
• Summary: summary