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: K160209
• 510k Number: K160209
• Device Name: Gold Anchor
• Classification: Accelerator, Linear, Medical
• Applicant: NASLUND MEDICAL AB VASSVAGEN 21 Huddinge, SE 14139
• Contact: Tomas Naslund
• Correspondent: Tomas Naslund; NASLUND MEDICAL AB VASSVAGEN 21 Huddinge, SE 14139
• Product Code: IYE
• CFR Regulation Number: 892.5050 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-01-28
• Decision Date: 2016-06-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07340145700735	K160209	000
07340145700261	K160209	000
07340145700247	K160209	000
07340145700230	K160209	000
07340145701237	K160209	000
07340145701213	K160209	000
07340145700674	K160209	000
07340145700650	K160209	000
07340145700599	K160209	000
07340145700513	K160209	000
07340145700452	K160209	000
07340145700285	K160209	000
07340145700315	K160209	000
07340145700339	K160209	000
07340145700711	K160209	000
07340145700629	K160209	000
07340145700575	K160209	000
07340145700551	K160209	000
07340145700490	K160209	000
07340145700476	K160209	000
07340145700414	K160209	000
07340145700391	K160209	000
07340145700377	K160209	000
07340145700353	K160209	000
07340145700438	K160209	000