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: K201117
• 510k Number: K201117
• Device Name: Gold Anchor
• Classification: Accelerator, Linear, Medical
• Applicant: Naslund Medical AB Avagen 40 B Huddinge, SE 14130
• Contact: Tomas Naslund
• Correspondent: Tomas Naslund; 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: 2020-04-27
• Decision Date: 2020-06-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07340145701053	K201117	000
07340145700810	K201117	000
07340145700797	K201117	000
07340145700773	K201117	000
07340145700759	K201117	000
07340145701190	K201117	000
07340145701176	K201117	000
07340145701152	K201117	000
07340145701138	K201117	000
07340145700834	K201117	000
07340145700858	K201117	000
07340145700872	K201117	000
07340145701039	K201117	000
07340145701015	K201117	000
07340145700995	K201117	000
07340145700971	K201117	000
07340145700957	K201117	000
07340145700933	K201117	000
07340145700919	K201117	000
07340145700896	K201117	000
07340145701077	K201117	000