Relizorb

Enzyme Packed Cartridge

Alcresta Therapeutics, Inc.

The following data is part of a premarket notification filed by Alcresta Therapeutics, Inc. with the FDA for Relizorb.

Pre-market Notification Details

• Device ID: K161247
• 510k Number: K161247
• Device Name: Relizorb
• Classification: Enzyme Packed Cartridge
• Applicant: Alcresta Therapeutics, Inc. One Newton Executive Park, Suite 102 Newton, MA 02462
• Contact: Robert Gallotto
• Correspondent: Nandini Murthy; Alcresta Therapeutics, Inc. One Newton Executive Park, Suite 102 Newton, MA 02462
• Product Code: PLQ
• CFR Regulation Number: 876.5985 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-05-03
• Decision Date: 2016-06-30
• Summary: summary