ALCOHOL PREP AND POVIDONE-IODINE PREP— 510(k) K896835

Name: FDA 510(k) clearance K896835
Creator: U.S. Food and Drug Administration
Published: 1990-01-11

Substantially Equivalent

Norpak Mfg., Inc.

FDA 510(k) clearance K896835 for ALCOHOL PREP AND POVIDONE-IODINE PREP, Substantially Equivalent on 1990-01-11. Applicant: Norpak Mfg., Inc.. Device class: Unclassified.

Clearance details

Applicant: Norpak Mfg., Inc.
Product code: Code LKB
Device class: Unclassified
Advisory panel: Unknown
Date received: 1989-12-05
Decision date: 1990-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ajax, Ontario L1z 1e2, CA

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LKB

product code LKB

Other: 2
Total: 2

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.