STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE— 510(k) K090929

Name: FDA 510(k) clearance K090929
Creator: U.S. Food and Drug Administration
Published: 2009-06-12

Substantially Equivalent

Shanghai Double Dove Industrial Co., Ltd.

FDA 510(k) clearance K090929 for STERILE HYPODERMIC SYRINGE AND NEEDLE FOR SINGLE USE, STERILE INSULING SYRINGE FOR SINGLE USE WITH FIXED NEEDLE, Substantially Equivalent on 2009-06-12. Applicant: Shanghai Double Dove Industrial Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shanghai Double Dove Industrial Co., Ltd.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2009-04-02
Decision date: 2009-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.