FREEHAND

Laparoscope, General & Plastic Surgery

PROSURGICS LIMITED

The following data is part of a premarket notification filed by Prosurgics Limited with the FDA for Freehand.

Pre-market Notification Details

• Device ID: K090340
• 510k Number: K090340
• Device Name: FREEHAND
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: PROSURGICS LIMITED 377 ROUTE 17S Hasbrouck Heights, NJ 07604
• Contact: Geroge Myers
• Correspondent: Geroge Myers; PROSURGICS LIMITED 377 ROUTE 17S Hasbrouck Heights, NJ 07604
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-02-10
• Decision Date: 2009-05-22
• Summary: summary