XOMED SILICONE BLOCK/STRIP— 510(k) K970910

Substantially Equivalent

Xomed, Inc.

FDA 510(k) clearance K970910 for XOMED SILICONE BLOCK/STRIP, Substantially Equivalent on 1997-05-02. Applicant: Xomed, Inc.. Device class: 2.

Clearance details

Applicant: Xomed, Inc.
Product code: Code KHJ
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 1997-03-12
Decision date: 1997-05-02
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.