T-GUARD

Device, Finger-sucking

MED ET AL DEVELOPMENT

The following data is part of a premarket notification filed by Med Et Al Development with the FDA for T-guard.

Pre-market Notification Details

• Device ID: K945537
• 510k Number: K945537
• Device Name: T-GUARD
• Classification: Device, Finger-sucking
• Applicant: MED ET AL DEVELOPMENT 815 TADLOCK PL. Matthews, NC 28105
• Contact: E Zilber
• Correspondent: E Zilber; MED ET AL DEVELOPMENT 815 TADLOCK PL. Matthews, NC 28105
• Product Code: LQX
• CFR Regulation Number: 890.3475 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-11-14
• Decision Date: 1995-03-23