ORWO X-RAY FILM— 510(k) K920539

Substantially Equivalent

Burkhart Roentgen Intl., Inc.

FDA 510(k) clearance K920539 for ORWO X-RAY FILM, Substantially Equivalent on 1992-06-30. Applicant: Burkhart Roentgen Intl., Inc.. Device class: 1.

Clearance details

Applicant: Burkhart Roentgen Intl., Inc.
Product code: Code IWZ
Device class: Class 1
Regulation: 21 CFR 892.1840
Advisory panel: Radiology
Date received: 1992-02-05
Decision date: 1992-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pinellas Park, FL, US

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More clearances from Burkhart Roentgen Intl., Inc.

K920538 — PROTECTIVE RADIOGRAFIC GLOVE1992-05-29
K920540 — RADIOLOGICAL PROTECTIVE EYE SHIELD1992-05-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.