OCTO

Laparoscope, General & Plastic Surgery

DALIM SURGNET CORPORATION

The following data is part of a premarket notification filed by Dalim Surgnet Corporation with the FDA for Octo.

Pre-market Notification Details

• Device ID: K100045
• 510k Number: K100045
• Device Name: OCTO
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: DALIM SURGNET CORPORATION 300 ATWOOD Pittsburgh, PA 15213
• Contact: Peter Chung
• Correspondent: Peter Chung; DALIM SURGNET CORPORATION 300 ATWOOD Pittsburgh, PA 15213
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-01-08
• Decision Date: 2010-06-25
• Summary: summary