L-12, L-21, AND L-22 ELECTRODES

Permanent Pacemaker Electrode

CORATOMIC, INC.

The following data is part of a premarket notification filed by Coratomic, Inc. with the FDA for L-12, L-21, And L-22 Electrodes.

Pre-market Notification Details

• Device ID: K780569
• 510k Number: K780569
• Device Name: L-12, L-21, AND L-22 ELECTRODES
• Classification: Permanent Pacemaker Electrode
• Applicant: CORATOMIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: DTB
• CFR Regulation Number: 870.3680 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1978-04-11
• Decision Date: 1978-06-14