Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch— 510(k) K193561

Substantially Equivalent

Weihai Xingtai Packaging Products Co., Ltd.

FDA 510(k) clearance K193561 for Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch, Substantially Equivalent on 2020-04-15. Applicant: Weihai Xingtai Packaging Products Co., Ltd..

Clearance details

Applicant
Weihai Xingtai Packaging Products Co., Ltd.
Product code
Code FRG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Weihai, 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.