Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)— 510(k) K182184

Substantially Equivalent

Mdk (Shanghai) Medical Packing Co., Ltd.

FDA 510(k) clearance K182184 for Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted), Substantially Equivalent on 2019-10-10. Applicant: Mdk (Shanghai) Medical Packing Co., Ltd..

Clearance details

Applicant
Mdk (Shanghai) Medical Packing Co., Ltd.
Product code
Code FRG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Shanghai, CN
Download summary PDFView on FDA.gov ↗

Adverse events under product code FRG

product code FRG
Other
3
Total
3

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.