SODIUM

Electrode, Ion Specific, Sodium

GAMMA ENTERPRISES, INC.

The following data is part of a premarket notification filed by Gamma Enterprises, Inc. with the FDA for Sodium.

Pre-market Notification Details

• Device ID: K771839
• 510k Number: K771839
• Device Name: SODIUM
• Classification: Electrode, Ion Specific, Sodium
• Applicant: GAMMA ENTERPRISES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JGS
• CFR Regulation Number: 862.1665 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1977-09-21
• Decision Date: 1977-11-02