STEPPER

Dispenser, Liquid Medication

TRIDAK

The following data is part of a premarket notification filed by Tridak with the FDA for Stepper.

Pre-market Notification Details

• Device ID: K771539
• 510k Number: K771539
• Device Name: STEPPER
• Classification: Dispenser, Liquid Medication
• Applicant: TRIDAK 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: KYX
• CFR Regulation Number: 880.6430 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1977-08-11
• Decision Date: 1977-10-07