CO2 PNEUMO-DISSECTOR

Laparoscope, Gynecologic (and Accessories)

COOK UROLOGICAL, INC.

The following data is part of a premarket notification filed by Cook Urological, Inc. with the FDA for Co2 Pneumo-dissector.

Pre-market Notification Details

• Device ID: K972647
• 510k Number: K972647
• Device Name: CO2 PNEUMO-DISSECTOR
• Classification: Laparoscope, Gynecologic (and Accessories)
• Applicant: COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460
• Contact: Tammy Bacon
• Correspondent: Tammy Bacon; COOK UROLOGICAL, INC. 1100 WEST MORGAN ST. P.O. BOX 227 Spencer, IN 47460
• Product Code: HET
• CFR Regulation Number: 884.1720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-07-15
• Decision Date: 1998-04-10
• Summary: summary