Nustat XR

Dressing, Wound, Drug

Beeken Biomedical, LLC

The following data is part of a premarket notification filed by Beeken Biomedical, Llc with the FDA for Nustat Xr.

Pre-market Notification Details

• Device ID: K160578
• 510k Number: K160578
• Device Name: Nustat XR
• Classification: Dressing, Wound, Drug
• Applicant: Beeken Biomedical, LLC 292-G Page Street Stoughton, MA 02072
• Contact: Dan O'hara
• Correspondent: Susan Finneran; REGULATORY COMPLIANCE EXPERTS, INC. 186 OLD FARM RD Abington, MA 02351
• Product Code: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-03-01
• Decision Date: 2016-06-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00850392006582	K160578	000
00850392006155	K160578	000
00850392006018	K160578	000
00850392006506	K160578	000
00850392006704	K160578	000
00850392006179	K160578	000
00850392006223	K160578	000
00850392006230	K160578	000
00850392006247	K160578	000
00850392006254	K160578	000
00850392006261	K160578	000
00850392006278	K160578	000
00850392006513	K160578	000
00850392006520	K160578	000
00850392006537	K160578	000
00850392006551	K160578	000
00850392006568	K160578	000
00850392006575	K160578	000
00850392006100	K160578	000