Symphony

Dressing, Wound, Collagen

Aroa Biosurgery Ltd.

The following data is part of a premarket notification filed by Aroa Biosurgery Ltd. with the FDA for Symphony.

Pre-market Notification Details

• Device ID: K200413
• 510k Number: K200413
• Device Name: Symphony
• Classification: Dressing, Wound, Collagen
• Applicant: Aroa Biosurgery Ltd. 2 Kingsford Smith Place Airport Oaks, NZ 2022
• Contact: Tina O'brien
• Correspondent: Tina O'brien; Aroa Biosurgery Ltd. 2 Kingsford Smith Place Airport Oaks, NZ 2022
• Product Code: KGN
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-02-19
• Decision Date: 2020-07-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09421905067102	K200413	000
09421907331478	K200413	000
09421907331485	K200413	000
09421907331492	K200413	000
09421907331508	K200413	000
09421907331515	K200413	000
09421907331522	K200413	000
09421907331539	K200413	000
09421907331546	K200413	000
09421907331553	K200413	000
09421907331560	K200413	000
09421907331577	K200413	000
09421907331584	K200413	000
09421905067072	K200413	000
09421905067096	K200413	000
09421907331461	K200413	000