PREPPIES SKIN BARRIER WIPE— 510(k) K945675

Name: FDA 510(k) clearance K945675
Creator: U.S. Food and Drug Administration
Published: 1995-02-07

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K945675 for PREPPIES SKIN BARRIER WIPE, Substantially Equivalent on 1995-02-07. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health. Device class: Unclassified.

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code FRO
Device class: Unclassified
Advisory panel: Unknown
Date received: 1994-11-18
Decision date: 1995-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

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K973619 — KENDALL CURITY NON-ADHERING DRESSING1997-12-10
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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

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.