DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER— 510(k) K962290

Name: FDA 510(k) clearance K962290
Creator: U.S. Food and Drug Administration
Published: 1996-07-03

Substantially Equivalent

Debusk Technology Corp.

FDA 510(k) clearance K962290 for DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER, Substantially Equivalent on 1996-07-03. Applicant: Debusk Technology Corp.. Device class: 1.

Clearance details

Applicant: Debusk Technology Corp.
Product code: Code FOK
Device class: Class 1
Regulation: 21 CFR 880.5270
Advisory panel: General Hospital
Date received: 1996-06-14
Decision date: 1996-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Powell, TN, US

Download summary PDF View on FDA.gov ↗

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