CUTICOVER SKIN BARRIER DEVICE— 510(k) K042955

Name: FDA 510(k) clearance K042955
Creator: U.S. Food and Drug Administration
Published: 2006-06-19

Substantially Equivalent

D & D Holdings, LLC

FDA 510(k) clearance K042955 for CUTICOVER SKIN BARRIER DEVICE, Substantially Equivalent on 2006-06-19. Applicant: D & D Holdings, LLC. Device class: 1.

Clearance details

Applicant: D & D Holdings, LLC
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 2004-10-26
Decision date: 2006-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nashville, TN, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.