K041970

Substantially Equivalent

BIOTOP HOOKSAFE SAFETY SYRINGE, MODELS 0.5CC/ML, 1CC/ML, 3CC/ML, 5CC/ML AND 10CC/ML

Applicant: Biotop Technology Co., Ltd.
Product code: MEG
Advisory panel: General Hospital
Date received: 2004-07-22
Decision date: 2004-08-03
Decision: Substantially Equivalent
Clearance type: Special
Location: Hsin Chu City, TW

Adverse events under product code MEG

product code MEG

Malfunction: 1,373
Other: 1
Total: 1,374

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.