BH Sterilization Pouch— 510(k) K172280

Substantially Equivalent

Bh Medical Products Co., Ltd.

FDA 510(k) clearance K172280 for BH Sterilization Pouch, Substantially Equivalent on 2018-08-03. Applicant: Bh Medical Products Co., Ltd..

Clearance details

Applicant
Bh Medical Products Co., Ltd.
Product code
Code FRG
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Changzhou, 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.