LEEP SYSTEM 1000

Electrocautery, Gynecologic (and Accessories)

COOPERSURGICAL, INC.

The following data is part of a premarket notification filed by Coopersurgical, Inc. with the FDA for Leep System 1000.

Pre-market Notification Details

• Device ID: K952483
• 510k Number: K952483
• Device Name: LEEP SYSTEM 1000
• Classification: Electrocautery, Gynecologic (and Accessories)
• Applicant: COOPERSURGICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760
• Contact: Sheila Hemeon-heyer
• Correspondent: Sheila Hemeon-heyer; COOPERSURGICAL, INC. 49 PLAIN ST. North Attleboro, MA 02760
• Product Code: HGI
• CFR Regulation Number: 884.4120 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-05-30
• Decision Date: 1995-10-06