MEROCEL REINFORCED SILICONE SHEETS— 510(k) K953013

Name: FDA 510(k) clearance K953013
Creator: U.S. Food and Drug Administration
Published: 1995-08-29

Substantially Equivalent

Merocel Corp.

FDA 510(k) clearance K953013 for MEROCEL REINFORCED SILICONE SHEETS, Substantially Equivalent on 1995-08-29. Applicant: Merocel Corp.. Device class: 2.

Clearance details

Applicant: Merocel Corp.
Product code: Code KHJ
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 1995-06-29
Decision date: 1995-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jacksonville, FL, 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.