ALPHA MEDICA DISPOSABLE, STERILE, NONPYROGENIC SYRINGE— 510(k) K952553

Name: FDA 510(k) clearance K952553
Creator: U.S. Food and Drug Administration
Published: 1995-10-03

Substantially Equivalent

Alpha Medica

FDA 510(k) clearance K952553 for ALPHA MEDICA DISPOSABLE, STERILE, NONPYROGENIC SYRINGE, Substantially Equivalent on 1995-10-03. Applicant: Alpha Medica. Device class: 2.

Clearance details

Applicant: Alpha Medica
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 1995-06-01
Decision date: 1995-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mullins, SC, 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.