LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM

Laparoscope, General & Plastic Surgery

CORE DYNAMICS, INC.

The following data is part of a premarket notification filed by Core Dynamics, Inc. with the FDA for Laparoscopic Trocar Obturator, 5mm, 10/11mm, 10/12mm.

Pre-market Notification Details

• Device ID: K953903
• 510k Number: K953903
• Device Name: LAPAROSCOPIC TROCAR OBTURATOR, 5MM, 10/11MM, 10/12MM
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: CORE DYNAMICS, INC. 11222-4 ST. JOHNS INDUSTRIAL PARKWAY Jacksonville, FL 32246
• Contact: Bill Dennis
• Correspondent: Bill Dennis; CORE DYNAMICS, INC. 11222-4 ST. JOHNS INDUSTRIAL PARKWAY Jacksonville, FL 32246
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-07-20
• Decision Date: 1995-10-20

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30653405045452	K953903	000
30653405045445	K953903	000
30653405045438	K953903	000