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

K241123

Perpak™ Sterilization Tyvek Pouch

510(k) number
K241123
Device name
Perpak™ Sterilization Tyvek Pouch
Applicant
Km Corp. KR
Product code
FRG — Wrap, Sterilization
Decision date
2024-09-18
Date received
2024-04-23
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General Hospital
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain

Also available from FDA: K241123.pdf

Official FDA record: K241123
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.