DURQ/ QUALIDURA— 510(k) K013116
Substantially EquivalentEver-Safety Technical Service
FDA 510(k) clearance K013116 for DURQ/ QUALIDURA, Substantially Equivalent on 2002-01-18. Applicant: Ever-Safety Technical Service. Device class: 2.
Clearance details
- Applicant
- Ever-Safety Technical Service
- Product code
- Code BTA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taichung Hsien, Taiwan, CN
Recent devices under product code BTA
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- K260892 — Suction Pump (SU-90)
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- K253107 — Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)
Adverse events under product code BTA
product code BTA- Death
- 5
- Total
- 5
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.