Tellos ISQ Buddy

Handpiece, Direct Drive, Ac-powered

Tellos Medical AB

The following data is part of a premarket notification filed by Tellos Medical Ab with the FDA for Tellos Isq Buddy.

Pre-market Notification Details

• Device ID: K143445
• 510k Number: K143445
• Device Name: Tellos ISQ Buddy
• Classification: Handpiece, Direct Drive, Ac-powered
• Applicant: Tellos Medical AB Nedergardsgatan 5 Goteborg, SE 41654
• Contact: Anders Petersson
• Correspondent: Anders Petersson; Tellos Medical AB Nedergardsgatan 5 Goteborg, SE 41654
• Product Code: EKX
• CFR Regulation Number: 872.4200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2014-12-02
• Decision Date: 2016-01-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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