1.2 MICRON FILTER WITH IV SET— 510(k) K896292

Name: FDA 510(k) clearance K896292
Creator: U.S. Food and Drug Administration
Published: 1989-12-08

Substantially Equivalent

Kendall Mcgaw Laboratories, Inc.

FDA 510(k) clearance K896292 for 1.2 MICRON FILTER WITH IV SET, Substantially Equivalent on 1989-12-08. Applicant: Kendall Mcgaw Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Kendall Mcgaw Laboratories, Inc.
Product code: Code FPB
Device class: Class 2
Regulation: 21 CFR 880.5440
Advisory panel: General Hospital
Date received: 1989-10-31
Decision date: 1989-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Kendall Mcgaw Laboratories, Inc.

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K905610 — MICRORATE INTELLIGENT PUMP1991-03-01
K905611 — MICRORATE PLUS INTELLIGENT PUMP1991-03-01
K904855 — ADD-A-VIAL1990-11-19
K904518 — VOLUMETRIC INFUSION PUMP1990-10-17
K903809 — PROTECTED NEEDLE WITH OR WITHOUT IV SET1990-10-03

Adverse events under product code FPB

product code FPB

Other: 1
Total: 1

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.