CURAGEL HYDROGEL WOUND DRESSING— 510(k) K950412

Name: FDA 510(k) clearance K950412
Creator: U.S. Food and Drug Administration
Published: 1995-03-24

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K950412 for CURAGEL HYDROGEL WOUND DRESSING, Substantially Equivalent on 1995-03-24. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health. Device class: 1.

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code NAE
Device class: Class 1
Regulation: 21 CFR 878.4022
Advisory panel: General, Plastic Surgery
Date received: 1995-01-31
Decision date: 1995-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

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K973619 — KENDALL CURITY NON-ADHERING DRESSING1997-12-10
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Data sourced from openFDA. This site is unofficial and independent of the FDA.