Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K223126

SurgiAid® Collagen Wound Dressing

510(k) number
K223126
Device name
SurgiAid® Collagen Wound Dressing
Applicant
Maxigen Biotech, Inc. TW
Product code
KGN — Wound Dressing With Animal-Derived Material(S)
Decision date
2023-10-11
Date received
2022-10-03
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Unknown
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain

Also available from FDA: K223126.pdf

Official FDA record: K223126
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.