TIELLE* HYDROPOLYMER DRESSING— 510(k) K946245

Name: FDA 510(k) clearance K946245
Creator: U.S. Food and Drug Administration
Published: 1995-04-11

Substantially Equivalent

Johnson & Johnson International

FDA 510(k) clearance K946245 for TIELLE* HYDROPOLYMER DRESSING, Substantially Equivalent on 1995-04-11. Applicant: Johnson & Johnson International. Device class: 1.

Clearance details

Applicant: Johnson & Johnson International
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1994-12-22
Decision date: 1995-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TX, 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.