SALUTE

Staple, Implantable

ONUX MEDICAL, INC.

The following data is part of a premarket notification filed by Onux Medical, Inc. with the FDA for Salute.

Pre-market Notification Details

• Device ID: K003522
• 510k Number: K003522
• Device Name: SALUTE
• Classification: Staple, Implantable
• Applicant: ONUX MEDICAL, INC. 5 MERRILL DR. Hampton, NH 03842
• Contact: Gregory E Sancoff
• Correspondent: Gregory E Sancoff; ONUX MEDICAL, INC. 5 MERRILL DR. Hampton, NH 03842
• Product Code: GDW
• CFR Regulation Number: 878.4750 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-11-15
• Decision Date: 2001-02-13