FLUID DISPENSING SYSTEM— 510(k) K800362

Name: FDA 510(k) clearance K800362
Creator: U.S. Food and Drug Administration
Published: 1980-03-12

Substantially Equivalent

Pharmaseal Laboratories

FDA 510(k) clearance K800362 for FLUID DISPENSING SYSTEM, Substantially Equivalent on 1980-03-12. Applicant: Pharmaseal Laboratories. Device class: 1.

Clearance details

Applicant: Pharmaseal Laboratories
Product code: Code KYX
Device class: Class 1
Regulation: 21 CFR 880.6430
Advisory panel: General Hospital
Date received: 1980-02-20
Decision date: 1980-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KYX

product code KYX

Death: 3
Other: 8
Total: 11

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.