GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES— 510(k) K002569

Name: FDA 510(k) clearance K002569
Creator: U.S. Food and Drug Administration
Published: 2000-12-12

Substantially Equivalent

Malgam Ent., Inc.

FDA 510(k) clearance K002569 for GLUCOSOURCE INSULIN SYRINGES AND MALGAM SINGLE-USE INSULIN AND SINGLE USE HYPODERMIC SYRINGES, Substantially Equivalent on 2000-12-12. Applicant: Malgam Ent., Inc.. Device class: 2.

Clearance details

Applicant: Malgam Ent., Inc.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 2000-08-18
Decision date: 2000-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Francisco, CA, US

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.