Rochal Bioshield Silicone Film— 510(k) K182733

Name: FDA 510(k) clearance K182733
Creator: U.S. Food and Drug Administration
Published: 2019-06-27

Substantially Equivalent

Rochal Industries, LLC

FDA 510(k) clearance K182733 for Rochal Bioshield Silicone Film, Substantially Equivalent on 2019-06-27. Applicant: Rochal Industries, LLC. Device class: 1.

Clearance details

Applicant: Rochal Industries, LLC
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 2018-09-28
Decision date: 2019-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, 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.