ACETONE ALCOHOL PREP PAD— 510(k) K833185

Substantially Equivalent

Aplicare, Inc.

FDA 510(k) clearance K833185 for ACETONE ALCOHOL PREP PAD, Substantially Equivalent on 1983-10-31. Applicant: Aplicare, Inc..

Clearance details

Applicant: Aplicare, Inc.
Product code: Code LKB
Advisory panel: Unknown
Date received: 1983-09-19
Decision date: 1983-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.