POINT SETTER

Laparoscope, General & Plastic Surgery

MITAKA USA, INC.

The following data is part of a premarket notification filed by Mitaka Usa, Inc. with the FDA for Point Setter.

Pre-market Notification Details

• Device ID: K984355
• 510k Number: K984355
• Device Name: POINT SETTER
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: MITAKA USA, INC. 2337 LUCKY JOHN DR. Park City, UT 84060
• Contact: Max Sturgis
• Correspondent: Max Sturgis; MITAKA USA, INC. 2337 LUCKY JOHN DR. Park City, UT 84060
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-12-07
• Decision Date: 1999-04-01