Cleared Traditional

K200413 - Symphony (FDA 510(k) Clearance)

K200413 · Aroa Biosurgery , Ltd. · General & Plastic Surgery device

Jul 2020

Decision

161d

Days

Risk

K200413 is an FDA 510(k) clearance for the Symphony. This device is classified as a Wound Dressing With Animal-derived Material(s).

Submitted by Aroa Biosurgery , Ltd. (Mangere, NZ). The FDA issued a Cleared decision on July 29, 2020, 161 days after receiving the submission on February 19, 2020.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number	K200413 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 19, 2020
Decision Date	July 29, 2020
Days to Decision	161 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF