BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY— 510(k) K844625

Name: FDA 510(k) clearance K844625
Creator: U.S. Food and Drug Administration
Published: 1985-01-16

Substantially Equivalent

Bipore, Inc.

FDA 510(k) clearance K844625 for BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY, Substantially Equivalent on 1985-01-16. Applicant: Bipore, Inc.. Device class: 1.

Clearance details

Applicant: Bipore, Inc.
Product code: Code KOZ
Device class: Class 1
Regulation: 21 CFR 878.4018
Advisory panel: General, Plastic Surgery
Date received: 1984-11-27
Decision date: 1985-01-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Demarest, NJ, US

Download summary PDF View on FDA.gov ↗

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K896828 — BIOCLUSIVE(R) ABSORBENT DRESSING1990-11-21

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K041293 — BIOPORE BALLOON DILATION CATHETER2004-07-09
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Adverse events under product code KOZ

product code KOZ

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.