RADIOLOGICAL PROTECTIVE EYE SHIELD— 510(k) K920540

Name: FDA 510(k) clearance K920540
Creator: U.S. Food and Drug Administration
Published: 1992-05-28

Substantially Equivalent

Burkhart Roentgen Intl., Inc.

FDA 510(k) clearance K920540 for RADIOLOGICAL PROTECTIVE EYE SHIELD, Substantially Equivalent on 1992-05-28. Applicant: Burkhart Roentgen Intl., Inc.. Device class: 1.

Clearance details

Applicant: Burkhart Roentgen Intl., Inc.
Product code: Code IWS
Device class: Class 1
Regulation: 21 CFR 892.6500
Advisory panel: Radiology
Date received: 1992-02-05
Decision date: 1992-05-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pinellas Park, FL, US

Download summary PDF View on FDA.gov ↗

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