Gold Anchor

Accelerator, Linear, Medical

Naslund Medical AB

The following data is part of a premarket notification filed by Naslund Medical Ab with the FDA for Gold Anchor.

Pre-market Notification Details

• Device ID: K213053
• 510k Number: K213053
• Device Name: Gold Anchor
• Classification: Accelerator, Linear, Medical
• Applicant: Naslund Medical AB Avagen 40 B Huddinge, SE 14130
• Contact: Tomas Näslund
• Correspondent: Tomas Näslund; Naslund Medical AB Avagen 40 B Huddinge, SE 14130
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-22
• Decision Date: 2022-01-06

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07340145701114	K213053	000
07340145701091	K213053	000